A Phase 3 interventional study of cetuximab and cisplatin in Head and Neck Cancer and Precancerous Condition, sponsored by Radiation Therapy Oncology Group. Completed at 185 sites in 2 countries. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.
PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (≤ 10 pack-years vs > 10 pack-years). Patients are randomized to 1 of 2 treatment arms.
Patients may complete quality-of-life questionnaires and risk factors for head and neck cancer surveys at baseline, periodically during study, and at follow-up for 1 year.
After completion of study therapy, patients are followed up at 1-3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's enrollment of 987 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Radiation Therapy Oncology Group is the lead sponsor of 155 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical stage T1-2, N2a-N3 or T3-4, any N (AJCC, 7th ed.; see Appendix III), including no distant , based upon the following minimum diagnostic workup:
One of the following combinations of imaging is required within 8 weeks prior to registration:
Note: A CT scan of neck and/or a PET/CT performed for radiation planning and read by a radiologist may serve as both staging and planning tools.
Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function, defined as follows:
Adequate hepatic function, defined as follows:
Adequate renal function, defined as follows:
CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CCr male)
Exclusion Criteria:
Severe, active co-morbidity, defined as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin
Drug: cisplatin · Radiation: IMRT
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab
Biological: cetuximab · Radiation: IMRT
400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks
100 mg/m2 IV on days 1 and 22 of IMRT
35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Also known as: intensity-modulated radiotherapy, intensity-modulated radiation therapy
Overall Survival
An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Progression-free Survival
An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Time to Local-regional Failure
Failure for local-regional failure endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of local-regional failure times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Time to Distant Metastasis
Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of distant metastasis times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Time to Secondary Primary Cancer
Failure for second primary endpoint was defined as reporting of a new primary cancer; death due to any cause was considered a competing risk. Second primary time is defined as time from randomization to the date of second primary or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of second primary cancer times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Distribution of First Progression Events
The first event type for progression-free survival is counted for each participant. Possible first progression events are local, regional, or distant progression, any combination of these, or death. The frequency table of these events is also referred to as "Pattern of failure."
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Percentage of Participants Experiencing Early Death
Early death is defined as death due to adverse event or within 30 days of treatment completion.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment
Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time frame: From start of treatment to end of treatment, approximately 6 weeks
Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment
Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time frame: From start of treatment to approximately 2.5 months (1 month after the end of treatment)
Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment
Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time frame: From start of treatment to approximately 4.5 months (3 months after the end of treatment)
Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 6 Months After the End of Study Treatment
Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time frame: From start of treatment to approximately 7.5 months (6 months after the end of treatment)
Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 1 Year After the End of Study Treatment
Late adverse events (AE) are defined as \> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time frame: From start of treatment to approximately 13.5 months (one year after the end of treatment)
Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 2 Years After the End of Study Treatment
Late adverse events (AE) are defined as \> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time frame: From 180 days after end of treatment to two years after end of treatment.
Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 5 Years After the End of Study Treatment
Late adverse events (AE) are defined as \> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time frame: From start of treatment to approximately 61.5 months (five years after the end of treatment)
Percentage of Participants With a Feeding Tube at 1 Year
Time frame: From randomization to 1 year.
EORTC QLQ-C30 Global Health Status Score Change From Baseline at End of Treatment
The EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.
Time frame: Baseline and end of treatment (6-7 weeks)
EORTC QLQ-C30 Global Health Status Score Change From Baseline at 3 Months From End of Treatment
The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.
Time frame: Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.
EORTC QLQ-C30 Global Health Status Score Change From Baseline at 6 Months From End of Treatment
The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.
Time frame: Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.
EORTC QLQ-C30 Global Health Status Score Change From Baseline at 12 Months From End of Treatment
The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.
Time frame: Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks
EORTC QLQ-H&N35 Swallowing Score Change From Baseline at End of Treatment
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer Module (EORTC QLQ-H\&N35) swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
Time frame: Baseline and end of treatment (6-7 weeks)
EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 3 Months From End of Treatment.
The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
Time frame: Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.
EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 6 Months From End of Treatment.
The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
Time frame: Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.
EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 12 Months From End of Treatment.
The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
Time frame: Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks.
Number of Participants With Post-baseline Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Head and Neck (PRO-CTCAE H&N) Scores >= 3
PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values \< 0.05.
Time frame: End of treatment (approximately 6 weeks after baseline); and 3, 6, and 12 months after end of treatment (approximately 4.5, 7.5, and 13.5 months after baseline).
EuroQol Five Dimension Scale 3-level Version (EQ-5D-3L) Index Score Change From Baseline
The EQ-5D-3L index score measures health-related quality of life using five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three levels of severity (1 = no problems, 2 = moderate problems, 3 = extreme problems). Responses across the five items are combined and transformed into a single utility (index) score. Possible scores range from 0 to 1, with higher scores indicating a better outcome. The change score was calculated as the postbaseline value minus the baseline value. A negative change reflects decline at the postbaseline timepoint and a positive change reflects improvement at the postbaseline timepoint.
Time frame: Basline, end of treatment (6-7 weeks), and 3, 6, and 12 months from end of treatment.
EuroQol Five Dimension Scale 3-level Version (EQ-5D-3L) Visual Analogue Scale (VAS) Change From Baseline
The EQ-5D-3L VAS measures a patient's self-rated current health state using a visual analogue scale measured on a 20-cm scale with 10-point intervals. Scores range from 0 at the bottom of the scale, representing the worst imaginable health state, to 100 at the top of the scale, representing the best imaginable health state. The change score was calculated as the postbaseline value minus the baseline value. A negative change reflects decline at the postbaseline timepoint and a positive change reflects improvement at the postbaseline timepoint.
Time frame: Basline, end of treatment (6-7 weeks), and 3, 6, and 12 months from end of treatment.
Number of Participants by Work Status Category at Baseline
Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.
Time frame: Baseline
Number of Participants by Work Status Category at End of Treatment
Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.
Time frame: End of treatment (6-7 weeks)
Number of Participants by Work Status Category at 3 Months After End of Treatment
Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.
Time frame: Three months after end of treatment (6-7 weeks).
Number of Participants by Work Status Category at 6 Months After End of Treatment
Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.
Time frame: Six months after end of treatment (6-7 weeks).
Number of Participants by Work Status Category at 12 Months After End of Treatment
Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.
Time frame: Twelve months after end of treatment (6-7 weeks).
Percentage of Patients With Normal/Good Dental Health: Pretreatment
This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated." Ten year data is not yet available.
Time frame: Before treatment
Percentage of Patients With Normal/Good Dental Health: 1 Year After End of Treatment
This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated."
Time frame: 1 year after end of treatment (approximately 13.5 months)
Percentage of Patients With Normal/Good Dental Health: 2 Years After End of Treatment
This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated."
Time frame: 2 years after end of treatment (approximately 25.5 months)
Percentage of Patients With Normal/Good Dental Health: 5 Years After End of Treatment
This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated."
Time frame: 5 years after end of treatment (approximately 61.5 months)
Percentage of Patients With Normal/Good Dental Health: 10 Years After End of Treatment
This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated."
Time frame: 10 years after end of treatment (approximately 121.5 months)
Number of Participants by HHIA-S Category at Baseline
The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.
Time frame: Baseline
Number of Participants by HHIA-S Category at End of Treatment
The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.
Time frame: End of treatment (6-7 weeks)
Number of Participants by HHIA-S Category at 3 Months After End of Treatment
The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.
Time frame: 3 months after end of treatment. Treatment lasts 6-7 weeks.
Number of Participants by HHIA-S Category at 6 Months After End of Treatment
The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.
Time frame: 6 months after end of treatment. Treatment lasts 6-7 weeks.
Number of Participants by HHIA-S Category at 12 Months After End of Treatment
The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.
Time frame: 12 months after end of treatment. Treatment lasts 6-7 weeks.
Overall Survival by KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) Variant Status
KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.
Progression-free Survival by KRAS Variant Status
KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.
Overall Survival by Treatment Arm Within KRAS Variant Status Group
KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.
Progression-free Survival Within KRAS Variant Status
KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.
Overall Survival by Sex
NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Overall Survival by Ethnicity
NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Overall Survival by Race
NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years. Five-year rates are reported here.
| Milestone | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Started | 424 | 425 |
| Eligible | 406 | 399 |
| Started treatment | 398 | 394 |
| Ae assessed 1 month post-treatment (pt) | 369 | 363 |
| Ae assessed 3 months pt | 359 | 367 |
| Ae assessed 6 months pt | 361 | 352 |
| Ae assessment 1 year pt | 360 | 351 |
| Ae assessed 2 years pt | 311 | 303 |
| Ae assessed 5 years pt | 92 | 86 |
| Dental health assessed 1 year pt | 267 | 267 |
| Dental health assessed 2 years pt | 208 | 201 |
| Dental health assessed 5 years pt | 44 | 43 |
| Feeding tube assessed | 368 | 356 |
| Progressed | 76 | 122 |
| Completed | 406 | 399 |
| Not completed | 18 | 26 |
| Withdrew: Protocol violation | 17 | 23 |
| Withdrew: Hiv positive | 1 | 3 |
An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Overall Survival | 84.6 (80.6 to 88.6) | 77.9 (73.4 to 82.5) |
An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Progression-free Survival | 78.4 (73.8 to 83.0) | 67.3 (62.4 to 72.2) |
Failure for local-regional failure endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of local-regional failure times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Time to Local-regional Failure | 9.9 (6.9 to 13.6) | 17.3 (13.7 to 21.4) |
Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of distant metastasis times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Time to Distant Metastasis | 8.6 (5.8 to 11.9) | 11.7 (8.6 to 15.3) |
Failure for second primary endpoint was defined as reporting of a new primary cancer; death due to any cause was considered a competing risk. Second primary time is defined as time from randomization to the date of second primary or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of second primary cancer times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Time to Secondary Primary Cancer | 9.9 (6.9 to 13.4) | 10.3 (7.1 to 14.2) |
The first event type for progression-free survival is counted for each participant. Possible first progression events are local, regional, or distant progression, any combination of these, or death. The frequency table of these events is also referred to as "Pattern of failure."
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Local | 13 | 25 |
| Regional | 6 | 14 |
| Local and regional | 4 | 8 |
| Local and distant | 0 | 1 |
| Regional and distant | 0 | 5 |
| Local, regional, and distant | 0 | 2 |
| Distant | 31 | 43 |
| Death, due to this disease | 2 | 0 |
| Death, due to second primary | 1 | 3 |
| Death, due to other reason | 10 | 11 |
| Death, due to unknown reason | 9 | 10 |
Early death is defined as death due to adverse event or within 30 days of treatment completion.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Participants Experiencing Early Death | 1.5 (0.6 to 3.3) | 1.5 (0.6 to 3.3) |
Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment | 75.6 (71.1 to 79.8) | 73.6 (69.0 to 77.9) |
Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment | 32.5 (27.8 to 37.6) | 31.1 (26.4 to 36.2) |
Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment | 17.5 (13.8 to 21.9) | 14.7 (11.3 to 18.8) |
Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 6 Months After the End of Study Treatment | 13.3 (10.0 to 17.2) | 9.4 (6.5 to 12.9) |
Late adverse events (AE) are defined as \> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 1 Year After the End of Study Treatment | 10.0 (7.1 to 13.6) | 8.5 (5.8 to 12.0) |
Late adverse events (AE) are defined as \> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 2 Years After the End of Study Treatment | 7.7 (5.0 to 11.3) | 4.0 (2.1 to 6.8) |
Late adverse events (AE) are defined as \> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 5 Years After the End of Study Treatment | 4.3 (1.2 to 10.8) | 7.0 (2.6 to 14.6) |
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Participants With a Feeding Tube at 1 Year | 9.2 (6.5 to 12.7) | 8.4 (5.8 to 11.8) |
The EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.
| score on a scale | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| EORTC QLQ-C30 Global Health Status Score Change From Baseline at End of Treatment | -23.16 ± 28.16 | -25.31 ± 22.92 |
The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.
| score on a scale | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| EORTC QLQ-C30 Global Health Status Score Change From Baseline at 3 Months From End of Treatment | -4.42 ± 25.92 | -7.51 ± 22.46 |
The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.
| score on a scale | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| EORTC QLQ-C30 Global Health Status Score Change From Baseline at 6 Months From End of Treatment | -0.57 ± 25.01 | -0.90 ± 23.35 |
The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.
| score on a scale | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| EORTC QLQ-C30 Global Health Status Score Change From Baseline at 12 Months From End of Treatment | 3.15 ± 23.42 | 2.59 ± 21.09 |
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer Module (EORTC QLQ-H\&N35) swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
| score on a scale | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| EORTC QLQ-H&N35 Swallowing Score Change From Baseline at End of Treatment | 47.99 ± 27.99 | 47.43 ± 24.52 |
The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
| score on a scale | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 3 Months From End of Treatment. | 10.58 ± 26.49 | 14.20 ± 20.61 |
The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
| score on a scale | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 6 Months From End of Treatment. | 8.65 ± 23.94 | 10.13 ± 18.73 |
The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
| score on a scale | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 12 Months From End of Treatment. | 2.52 ± 19.64 | 7.61 ± 17.81 |
PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values \< 0.05.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Discouraged Feelings Frequency | 17 | 25 |
| Discouraged Feelings Severity | 13 | 13 |
| Discouraged Feelings Interference | 13 | 18 |
| Mouth Sores Severity | 96 | 84 |
| Mouth Sores Interference | 63 | 82 |
| Hair Loss Presence | 10 | 14 |
| Difficulty Swallowing Severity | 116 | 80 |
| Vomiting Frequency | 22 | 15 |
| Vomiting Severity | 25 | 17 |
| Heartburn Frequency | 26 | 22 |
| Heartburn Severity | 16 | 11 |
| Fatigue Severity | 67 | 61 |
| Fatigue Interference | 77 | 69 |
| Constipation Severity | 34 | 32 |
| Skin Radiation Severity | 46 | 57 |
| Ringing In Ears Severity | 54 | 7 |
| Nausea Frequency | 56 | 38 |
| Nausea Severity | 34 | 26 |
| Itching Severity | 18 | 15 |
| Dry Skin Severity | 21 | 28 |
| Decreased Appetite Severity | 75 | 78 |
| Decreased Appetite Interference | 47 | 53 |
| Dry Mouth Severity | 168 | 160 |
| Hoarseness Severity | 69 | 50 |
| Pain Frequency | 142 | 113 |
| Pain Severity | 98 | 64 |
| Pain Interference | 64 | 53 |
| Taste Change Severity | 159 | 148 |
| Diarrhea Frequency | 14 | 12 |
| Nail Loss Presence | 0 | 0 |
| Acne Severity | 5 | 20 |
| Numbness And Tingling Severity | 8 | 6 |
| Numbness And Tingling Interference | 6 | 3 |
| Cough Severity | 36 | 15 |
| Cough Interference | 23 | 11 |
| Rash Presence | 0 | 0 |
| Anxiety Frequency | 30 | 36 |
| Anxiety Severity | 13 | 20 |
| Anxiety Interference | 14 | 17 |
| Insomnia Severity | 54 | 38 |
| Insomnia Interference | 45 | 31 |
| Sad Feelings Frequency | 32 | 30 |
| Sad Feelings Severity | 18 | 15 |
| Sad Feelings Interference | 16 | 17 |
The EQ-5D-3L index score measures health-related quality of life using five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three levels of severity (1 = no problems, 2 = moderate problems, 3 = extreme problems). Responses across the five items are combined and transformed into a single utility (index) score. Possible scores range from 0 to 1, with higher scores indicating a better outcome. The change score was calculated as the postbaseline value minus the baseline value. A negative change reflects decline at the postbaseline timepoint and a positive change reflects improvement at the postbaseline timepoint.
| score on a scale | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| End of treatment | -0.15 ± 0.20 | -0.13 ± 0.21 |
| 3 months from end of treatment | -0.02 ± 0.15 | -0.01 ± 0.18 |
| 6 months from end of treatment | 0.00 ± 0.15 | 0.03 ± 0.15 |
| 12 months from end of treatment | 0.03 ± 0.15 | 0.03 ± 0.18 |
The EQ-5D-3L VAS measures a patient's self-rated current health state using a visual analogue scale measured on a 20-cm scale with 10-point intervals. Scores range from 0 at the bottom of the scale, representing the worst imaginable health state, to 100 at the top of the scale, representing the best imaginable health state. The change score was calculated as the postbaseline value minus the baseline value. A negative change reflects decline at the postbaseline timepoint and a positive change reflects improvement at the postbaseline timepoint.
| score on a scale | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| End of treatment | -18.01 ± 19.5 | -20.05 ± 21.33 |
| 3 months from end of treatment | -3.52 ± 18.47 | -4.38 ± 16.59 |
| 6 months from end of treatment | 2.70 ± 14.41 | 0.71 ± 16.15 |
| 12 months from end of treatment | 5.37 ± 20.45 | 2.93 ± 13.81 |
Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Currently working in at least one full-time job | 104 | 88 |
| Currently working in at least one part-time job | 13 | 16 |
| Not employed | 16 | 20 |
| Not working outside of the home | 10 | 7 |
| On disability | 19 | 13 |
| On sick leave | 13 | 15 |
| Retired | 30 | 31 |
| Student full time | 1 | 0 |
| Student part time | 0 | 0 |
| Other | 2 | 4 |
Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Currently working in at least one full-time job | 31 | 28 |
| Currently working in at least one part-time job | 8 | 7 |
| Not employed | 8 | 16 |
| Not working outside of the home | 26 | 18 |
| On disability | 25 | 29 |
| On sick leave | 36 | 33 |
| Retired | 23 | 19 |
| Student full time | 0 | 0 |
| Student part time | 1 | 0 |
| Other | 9 | 5 |
Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Currently working in at least one full-time job | 52 | 46 |
| Currently working in at least one part-time job | 12 | 13 |
| Not employed | 15 | 16 |
| Not working outside of the home | 18 | 21 |
| On disability | 20 | 28 |
| On sick leave | 12 | 18 |
| Retired | 23 | 23 |
| Student full time | 0 | 0 |
| Student part time | 0 | 0 |
| Other | 5 | 3 |
Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Currently working in at least one full-time job | 66 | 59 |
| Currently working in at least one part-time job | 19 | 12 |
| Not employed | 8 | 10 |
| Not working outside of the home | 13 | 18 |
| On disability | 25 | 21 |
| On sick leave | 0 | 0 |
| Retired | 24 | 27 |
| Student full time | 0 | 0 |
| Student part time | 1 | 1 |
| Other | 3 | 3 |
Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Currently working in at least one full-time job | 68 | 66 |
| Currently working in at least one part-time job | 10 | 6 |
| Not employed | 5 | 8 |
| Not working outside of the home | 8 | 10 |
| On disability | 13 | 16 |
| On sick leave | 0 | 0 |
| Retired | 23 | 33 |
| Student full time | 0 | 0 |
| Student part time | 0 | 0 |
| Other | 6 | 2 |
This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated." Ten year data is not yet available.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Patients With Normal/Good Dental Health: Pretreatment | 71.1 (66.4 to 75.5) | 74.6 (70.0 to 78.8) |
This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated."
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Patients With Normal/Good Dental Health: 1 Year After End of Treatment | 87.3 (82.7 to 91.0) | 83.5 (78.5 to 87.8) |
This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated."
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Patients With Normal/Good Dental Health: 2 Years After End of Treatment | 86.5 (81.1 to 90.9) | 82.1 (76.1 to 87.1) |
This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated."
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Patients With Normal/Good Dental Health: 5 Years After End of Treatment | 88.6 (75.4 to 96.2) | 86.0 (72.1 to 94.7) |
This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated."
| Percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Percentage of Patients With Normal/Good Dental Health: 10 Years After End of Treatment | 91.2 (76.3 to 98.1) | 84.0 (63.9 to 95.5) |
The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| No handicap | 150 | 132 |
| Mild-moderate handicap | 23 | 32 |
| Severe handicap | 2 | 7 |
The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| No handicap | 91 | 107 |
| Mild-moderate handicap | 29 | 21 |
| Severe handicap | 14 | 5 |
The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| No handicap | 93 | 109 |
| Mild-moderate handicap | 28 | 21 |
| Severe handicap | 15 | 7 |
The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| No handicap | 95 | 106 |
| Mild-moderate handicap | 31 | 21 |
| Severe handicap | 14 | 4 |
The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.
| Participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| No handicap | 84 | 103 |
| Mild-moderate handicap | 27 | 17 |
| Severe handicap | 10 | 5 |
KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | Variant | Non-variant |
|---|---|---|
| Overall Survival by KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) Variant Status | 80.6 (72.3 to 88.9) | 79.2 (75.4 to 83.0) |
KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | Variant | Non-variant |
|---|---|---|
| Progression-free Survival by KRAS Variant Status | 72.0 (62.6 to 81.3) | 71.5 (67.3 to 75.7) |
KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Variant | 83.3 (72.0 to 94.6) | 78.4 (66.5 to 90.3) |
| Non-variant | 80.8 (75.6 to 86.1) | 77.6 (72.2 to 83.1) |
KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Variant | 76.6 (63.9 to 89.3) | 67.7 (54.2 to 81.2) |
| Non-variant | 75.1 (69.4 to 80.8) | 68.0 (62.0 to 74.1) |
NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Female | 93.4 (84.6 to 100) | 76.8 (62.8 to 90.8) |
| Male | 83.8 (79.6 to 88.1) | 78.0 (73.2 to 82.9) |
NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Hispanic or Latino | 100 (NA to NA) | 70.7 (46.5 to 95.0) |
| Not Hispanic or Latino | 84.7 (80.6 to 88.8) | 77.9 (73.2 to 82.7) |
| Unknown or Not Reported | 66.8 (35.1 to 98.6) | 85.7 (67.4 to 100) |
NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
| percentage of participants | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| American Indian or Alaska Native | — | 100 (NA to NA) |
| Asian | NA (NA to NA) | 100 (NA to NA) |
| Native Hawaiian or Other Pacific Islander | — | NA (NA to NA) |
| Black or African American | 77.5 (54.9 to 100) | 76.4 (55.9 to 96.9) |
| White | 84.6 (80.5 to 88.7) | 77.3 (72.5 to 82.1) |
| More than one race | — | NA (NA to NA) |
| Unknown or Not Reported | 100 (NA to NA) | 100 (NA to NA) |
Collected over From randomization to last follow-up. Maximum follow-up was 7.4 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IMRT + Cisplatin | 64/406 (15.8%) | 177/398 (44.5%) | 398/398 (100%) |
| IMRT + Cetuximab | 86/399 (21.6%) | 115/394 (29.2%) | 393/394 (99.7%) |
| Event | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| DehydrationMetabolism and nutrition disorders | 43/398 | 20/394 |
| NauseaGastrointestinal disorders | 38/398 | 18/394 |
| VomitingGastrointestinal disorders | 34/398 | 14/394 |
| DysphagiaGastrointestinal disorders | 23/398 | 17/394 |
| Mucositis oralGastrointestinal disorders | 18/398 | 22/394 |
| Acute kidney injuryRenal and urinary disorders | 21/398 | 1/394 |
| Febrile neutropeniaBlood and lymphatic system disorders | 14/398 | 1/394 |
| Neutrophil count decreasedInvestigations | 13/398 | 0/394 |
| PainGeneral disorders and administration site conditions | 12/398 | 9/394 |
| Lymphocyte count decreasedInvestigations | 12/398 | 11/394 |
| Event | IMRT + Cisplatin | IMRT + Cetuximab |
|---|---|---|
| Dry mouthGastrointestinal disorders | 376/398 | 372/394 |
| Mucositis oralGastrointestinal disorders | 363/398 | 370/394 |
| DysphagiaGastrointestinal disorders | 371/398 | 351/394 |
| FatigueGeneral disorders and administration site conditions | 357/398 | 345/394 |
| DysgeusiaNervous system disorders | 349/398 | 334/394 |
| PainGeneral disorders and administration site conditions | 329/398 | 324/394 |
| Dermatitis radiationInjury, poisoning and procedural complications | 316/398 | 305/394 |
| Rash acneiformSkin and subcutaneous tissue disorders | 21/398 | 300/394 |
| NauseaGastrointestinal disorders | 301/398 | 238/394 |
| AnorexiaMetabolism and nutrition disorders | 263/398 | 253/394 |
Eligible participants
| Age, Continuous(years) | IMRT + Cisplatin | IMRT + Cetuximab | Total |
|---|---|---|---|
| Median | 58 (52 to 63) | 58 (52 to 63) | 58 (52 to 63) |
| Age, Customized(Participants) | IMRT + Cisplatin | IMRT + Cetuximab | Total |
|---|---|---|---|
| <= 65 | 344 | 345 | 689 |
| > 65 | 62 | 54 | 116 |
| Sex: Female, Male(Participants) | IMRT + Cisplatin | IMRT + Cetuximab | Total |
|---|---|---|---|
| Female | 33 | 44 | 77 |
| Male | 373 | 355 | 728 |
| Ethnicity (NIH/OMB)(Participants) | IMRT + Cisplatin | IMRT + Cetuximab | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 15 | 26 |
| Not Hispanic or Latino | 383 | 369 | 752 |
| Unknown or Not Reported | 12 | 15 | 27 |
| Race/Ethnicity, Customized(Participants) | IMRT + Cisplatin | IMRT + Cetuximab | Total |
|---|---|---|---|
| White | 380 | 367 | 747 |
| Black | 17 | 19 | 36 |
| Other | 2 | 8 | 10 |
| Unknown | 7 | 5 | 12 |
| Zubrod performance status(Participants) | IMRT + Cisplatin | IMRT + Cetuximab | Total |
|---|---|---|---|
| 0 | 295 | 300 | 595 |
| 1 | 111 | 99 | 210 |
| Smoking history(Participants) | IMRT + Cisplatin | IMRT + Cetuximab | Total |
|---|---|---|---|
| 0 pack-years | 194 | 181 | 375 |
| >0 to <= 10 pack-years | 59 | 68 | 127 |
| >10 pack-years | 153 | 150 | 303 |
| Smoking history(pack-years) | IMRT + Cisplatin | IMRT + Cetuximab | Total |
|---|---|---|---|
| Median | 2 (0 to 22) | 3 (0 to 24) | 2 (0 to 23) |
5 further baseline measures are reported on the registry.
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Studies of the drugs tested here: Cetuximab · Cisplatin
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