An interventional study of 70 gy 35 fractions/7weeks+high dose of cisplatin and 81.6 Gy /68 fractions BID FOR 7 WEEKS in Head and Neck (HNSCC), sponsored by King Hussein Cancer Center. Recruiting at 1 site in Jordan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by King Hussein Cancer Center · Not applicable, Interventional, and Treatment
This is an international multi-centre, non-inferiority phase III randomized controlled trial comparing concurrent chemoradiation with high dose cisplatin (Arm A) vs. hyperfractionated radiation therapy (Arm B) in patients with head and neck squamous cell carcinoma.
This is an interventional randomized study in patients with head and neck squamous cell carcinoma , i twill compare between 2 arms (concurrent chemoradiation with high dose cisplatin (Arm A) vs. hyperfractionated radiation therapy (Arm B)
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 604 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →King Hussein Cancer Center is the lead sponsor of 23 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients with pathologically (histologically or cytologically) proven diagnosis of HNSCC (larynx, hypopharynx, or oropharynx). Pathologic confirmation may be from either nodal or primary tumour. If a is obtained from nodal disease, a clinically apparent primary tumour on imaging and/or clinical examination must be present.
Diagnostic tonsillectomy or local excision of the primary without removal of nodal disease is permitted.
Diagnostic lymph node excision or limited neck dissections (retrieving ≤ 4 nodes) are permitted HPV positive or negative (by p16 immunohistochemistry). OPC will be classified as p16 at local sites based on greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining.
For patients with OPC: analysis of p16 status is required For patients with laryngeal/hypopharyngeal cancer: analysis of p16 status is NOT required
Clinical stage T1-2 N1-2 M0 or T3 N0-2 M0 (UICC/AJCC TNM 8th Edition). Staging will be determined based on clinical examination, axial imaging (CT and/or MRI), and whenever available, PET-CT imaging.
The following radiological investigations must be done within 8 weeks of registration:
CT or MRI of the head and neck; PET-CT scan or chest CT scan (PET-CT scan is strongly preferred and highly recommended to be used for eligibility).
Planned definitive RT. Based on clinical and laboratory evaluation and in keeping with local institutional standards, the treating oncologist must declare upfront, that in the absence of the present clinical trial, the patient would be candidate for treatment with concurrent high dose cisplatin every 3 weeks. This would include:
Adequate hematologic function must be documented within 8 weeks prior to registration:
levels of > 8g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8 g/dL is acceptable) count of >100,000 cells/mm3. of > 1500 cells/mm3.
Adequate hepatic function must be documented within 8 weeks prior to registration:
Total \< 2 X institutional . (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal. Albumin ≥ 3.0 g/dL.
Adequate renal function must be documented within 8 weeks prior to registration:
Serum creatinine \< 1.5 mg/dl or (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
Patients known to be (HIV)+ are permitted.
Patients with >200 and serum HIV viral load of \< 200 copies/mm3 are eligible
HIV+ patients must receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management.
HIV testing is not required for eligibility. Must be ≥ 18 years of age.
Must have an (ECOG) performance status of 0-1.
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
Patient is able (i.e. sufficiently fluent) and willing to complete the PRO questionnaires in English or Arabic. The baseline assessment must be completed within required timelines, prior to treatment start. Inability (lack of comprehension in English/Arabic, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study.
Consent to provision of samples of blood and plasma for correlative studies is optional.
The treatment team must be able to commence definitive RT within 6 weeks of randomization.
Women of child bearing potential must use an accepted and effective method of and/or abstain from sexual intercourse while on protocol treatment and for at least 6 months after the last day of RT. Sexually active males must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 6 months after the last day of RT.
Women must not be pregnant or breast-feeding (Women in childbearing period will be instructed by treating physician to avoid pregnancy during and 6 months after end of RT). All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 4 weeks prior to registration. All breastfeeding women should discontinue breastfeeding prior to study registration.
Participants must not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs.
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Exclusion Criteria:Patients who fulfill any of the following criteria are not eligible for admission to the study:
HNC Patients with any of the following clinical stages/categories:
cT1-2 N0 M0 cT4 cN3 cM1
Patients with primary oral cavity cancer, nasopharynx cancer, or HNC of unknown primary.
Previous HNC or multiple synchronous primary HNCs.
Previous induction or chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded.
Previous RT to the head and neck or neck dissection of at least 3 levels on either side.
Patients with severe, active co-morbidity including any of the following:
or other pulmonary illness requiring hospitalization within 30 days of registration Unstable angina and/or congestive heart failure requiring hospitalization within 6 months of registration Acute myocardial infarction within 6 months of study registration Diseases precluding RT (e.g. scleroderma) Persistent grade 3-4 ( v5) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing Active infection requiring IV antibiotics prior to registration; Chronic renal disease e.g., nephrotic syndrome, that could be worsened by cisplatin therapy History of allogenic organ transplantation Any symptomatic peripheral sensory neuropathy grade ≥ 2 (CTCAE v5)
Prior invasive (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
Prior allergic reaction to cisplatin
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.
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.
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).
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 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.
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.
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.
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.
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.
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.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
concurrent chemoradiation with high dose cisplatin (Arm A) ) in patients with head and neck squamous cell carcinoma
Radiation: 70 gy 35 fractions/7weeks+high dose of cisplatin
hyperfractionated radiation therapy 81.6 Gy
Radiation: 81.6 Gy /68 fractions BID FOR 7 WEEKS
70 Gy 35 fractions/7weeks+high dose of cisplatin
81.6 Gy /68 fractions BID FOR 7 WEEKS
OVERALL SURVIVAL
To determine if hyperfractionated radiation therapy (Arm B) has a non-inferior overall survival (OS) compared to concurrent chemoradiation (CRT) with high dose cisplatin every 3 weeks (Arm A) in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC).
Time frame: 7 YEARS
Oncologic outcomes
To compare between arms the following: Oncologic outcomes: loco-regional failure (LRF)
Time frame: 7 YEARS
Change in hearing threshold levels as assessed by pure tone audiometry
Hearing threshold levels will be measured using pure tone audiometry across standard audiometric frequencies. Changes from baseline hearing thresholds will be assessed and compared between study groups
Time frame: 7 YEARS
Treatment-related toxicity/adverse events
Treatment-related toxicity/adverse events: physician-assessed toxicities: National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) v.5
Time frame: 7 YEARS
Change from baseline in Head and Neck Cancer-specific quality of life as assessed by the University of Washington Quality of Life Questionnaire
Patient-reported quality of life and swallowing-related quality of life will be assessed using the University of Washington Quality of Life Questionnaire (UW-QOL) . Questionnaire with higher scores indicating better quality of life and swallowing function. Change from baseline scores will be evaluated at predefined study time points
Time frame: 7 YEARS
Distant metastasis (DM) rate between treatment arms
he occurrence of distant metastases will be assessed and compared between study arms during the study follow-up period
Time frame: From randomisation till 7 years for each study participant
disease-free survival (DFS)
Disease-free survival (DFS) will be defined as the time from randomization to the first occurrence of disease recurrence (local, regional, or distant) or death from any cause, whichever occurs first
Time frame: 7 years
Change from baseline in ototoxicity severity as assessed by the Modified TUNE grading scale
Ototoxicity severity will be evaluated using the Modified TUNE grading scale. The scale grades hearing impairment severity based on audiologic assessment findings. Changes from baseline grading scores will be assessed and compared at predefined study time points, with higher grades indicating worse ototoxicity.
Time frame: 7 years
Change from baseline in speech recognition as assessed by Consonant-Nucleus-Consonant (CNC) word scores
Speech recognition ability will be evaluated using speech audiometry with Consonant-Nucleus-Consonant (CNC) word testing. CNC word scores will be reported as the percentage of correctly identified words, with higher scores indicating better speech recognition performance. Changes from baseline scores will be assessed at predefined study time points
Time frame: 7 years
Number of participants with abnormal tympanometry findings
Tympanometry will be performed to assess middle ear function. Tympanogram results will be classified according to standard tympanogram types, and the number of participants with abnormal findings will be reported at predefined study time points.
Time frame: 7 years
Treatment-related toxicity/adverse events-PRO
Treatment-related toxicity/adverse events: patient-reported toxicity: Patient Reported Outcomes - Common Terminology Criteria of Adverse Events (PRO CTCAE) v1.
Time frame: 7 years
Patient-reported outcomes (PRO):UW-QOL
Patient-reported outcomes (PRO): instrument \[University of Washington Quality of Life Questionnaire (UW-QOL)\]
Time frame: 7 years
Patient-reported outcomes (PRO): MDADI
swallowing-related PRO \[M.D. Anderson Dysphagia Inventory (MDADI)\]
Time frame: 7 Years
Change from baseline in Head and Neck Cancer-specific quality of life as assessed by the M. D. Anderson Dysphagia Inventory (MDADI)
Patient-reported quality of life and swallowing-related quality of life will be assessed using the M. D. Anderson Dysphagia Inventory (MDADI). Questionnaire with higher scores indicating better quality of life and swallowing function. Change from baseline scores will be evaluated at predefined study time points
Time frame: 7 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Apr 2033, 79 months after the start.
Of 115 non-industry interventional studies with no phase under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 90. This study's planned 79 months is above that.
Counting every sponsor, half of 126 studies reached it within 59 months; a quarter within 34 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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King Hussein Cancer Center