A Phase 2 interventional study of Intensity Modulated Radiation Therapy and chemotherapy in Head and Neck Cancer, Carcinoma, Squamous Cell and Neoplasms, Oral, sponsored by University of Texas Southwestern Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Treatment
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
This study aims to significantly improve the acute and late morbidity of patients with oropharyngeal and laryngeal squamous cell carcinoma both by tailoring the elective irradiation only to regions with a legitimate risk of recurrence (> 5%) and by lowering the elective dose to 40 Gy. Level IB will not be electively treated unless it is involved with pathologic or suspicious lymphadenopathy. Level V will not be treated unless two or more ipsilateral nodal levels are involved (or level V itself has pathologic or suspicious adenopathy). Levels III and IV will only be irradiated if the immediately proximal level contains pathologic lymphadenopathy (i.e. level III irradiated if level II is positive; level IV irradiated if level III is positive). We anticipate that this approach should dramatically improve the acute and late complication profile.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 72 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Exclusion Criteria:
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Radiation: Intensity Modulated Radiation Therapy · Drug: chemotherapy
The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
Also known as: IMRT
chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
Also known as: cisplatin, cetuximab, or carboplatin-paclitaxel
Number of Patients With Solitary Elective Volume Recurrence
The crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years. Patients who die before 2 years without an SEVR will be included in the denominator.
Time frame: 2 years
Quality of Life (QOL) Patient Reported Outcomes (PRO)
Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI). EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms. MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.
Time frame: 12 months
Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5)
Only adverse events (grade 3-5) assessed to be definitely, probably, or possibly related to protocol treatment up to 2 years post-treatment will be considered. This was measured according to NCI's CTCAE v4.0 toxicity criteria.
Time frame: 2 years
Total Number of Participants With Gastrostomy Dependence
The prevalence of gastrostomy use up to 2 years will be described.
Time frame: 2 years
Patient Utilities
The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described. Changes in patient utility will be analyzed using generalized estimated equations (GEE).
Time frame: 2 years
Overall Survival
Overall survival will be calculated from the initiation of treatment using the Kaplan-Meier method.
Time frame: 2 years
Progression-free Survival
Progression-free survival will be calculated from the initiation of treatment. Progression is confirmed by biopsy, which will be used as the date of progression.
Time frame: 2 year
Probability of Locoregional or Distant Tumor Failure
The percentage of patients with locoregional or distant failure within 2 years of treatment will be estimated using cumulative incidence statistics, with death serving as the competing risk. Cumulative incidence refers to the estimated risk/probability of tumor failure within 2 years of treatment, either locoregional recurrence or distant metastasis, accounting for the competing risk of death.
Time frame: 2 years
| Milestone | Radiation Therapy |
|---|---|
| Started | 72 |
| Completed | 72 |
| Not completed | 0 |
The crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years. Patients who die before 2 years without an SEVR will be included in the denominator.
| Participants | Radiation Therapy |
|---|---|
| Number of Patients With Solitary Elective Volume Recurrence | 0 |
Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI). EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms. MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.
| score on a scale | Total Cohort Baseline | Total Cohort 3 Month | Total Cohort 6 Month | Total Cohort 12 Month |
|---|---|---|---|---|
| EORTC QLQ30 global | 71.4 ± 2.3 | 76.9 ± 2.6 | 79.2 ± 2.8 | 85.9 ± 2.3 |
| EORTC QLQ30 physical fcn | 90.3 ± 1.7 | 87.4 ± 2.3 | 90.3 ± 2.4 | 93.0 ± 1.8 |
| EORTC QLQ30 role fcn | 81.9 ± 3.0 | 82.5 ± 3.4 | 85.6 ± 3.6 | 95.3 ± 2.2 |
| EORTC QLQ30 emotional fcn | 78.0 ± 2.8 | 87.7 ± 2.7 | 82.9 ± 3.7 | 88.2 ± 3.2 |
| EORTC QLQ30 cognitive fcn | 90.0 ± 1.9 | 89.5 ± 2.7 | 86.4 ± 3.1 | 90.7 ± 2.9 |
| EORTC QLQ30 social fcn | 85.2 ± 2.4 | 85.1 ± 3.5 | 85.6 ± 3.7 | 90.3 ± 3.4 |
| EORTC HN35 dry mouth | 14.4 ± 2.8 | 59.0 ± 4.1 | 47.7 ± 4.5 | 38.0 ± 4.2 |
| EORTC HN35 sticky saliva | 15.7 ± 3.2 | 38.0 ± 4.4 | 27.3 ± 4.4 | 27.1 ± 4.6 |
| EORTC HN35 senses | 6.7 ± 1.8 | 25.7 ± 2.9 | 20.1 ± 3.3 | 15.9 ± 2.7 |
| EORTC HN35 pain | 24.4 ± 2.7 | 16.5 ± 2.7 | 14.2 ± 3.3 | 7.9 ± 2.3 |
| EORTC HN35 speech | 18.4 ± 2.9 | 13.4 ± 2.6 | 19.2 ± 4.5 | 9.8 ± 2.6 |
| Composite MDADI | 81.3 ± 1.9 | 79.6 ± 2.0 | 76.9 ± 2.6 | 84.9 ± 2.3 |
Only adverse events (grade 3-5) assessed to be definitely, probably, or possibly related to protocol treatment up to 2 years post-treatment will be considered. This was measured according to NCI's CTCAE v4.0 toxicity criteria.
| Participants | Radiation Therapy |
|---|---|
| Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5) | 3 |
The prevalence of gastrostomy use up to 2 years will be described.
| Participants | Radiation Therapy |
|---|---|
| Total Number of Participants With Gastrostomy Dependence | 31 |
The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described. Changes in patient utility will be analyzed using generalized estimated equations (GEE).
No measurements were reported for this outcome.
Overall survival will be calculated from the initiation of treatment using the Kaplan-Meier method.
| percentage of patients | Radiation Therapy |
|---|---|
| Overall Survival | 89 |
Progression-free survival will be calculated from the initiation of treatment. Progression is confirmed by biopsy, which will be used as the date of progression.
| percentage of patients | Radiation Therapy |
|---|---|
| Progression-free Survival | 79 |
The percentage of patients with locoregional or distant failure within 2 years of treatment will be estimated using cumulative incidence statistics, with death serving as the competing risk. Cumulative incidence refers to the estimated risk/probability of tumor failure within 2 years of treatment, either locoregional recurrence or distant metastasis, accounting for the competing risk of death.
| percentage of patients | Radiation Therapy |
|---|---|
| Locoregional recurrence | 14 |
| Distant metastasis | 14 |
Collected over 30 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiation Therapy | 1/72 (1.4%) | 35/72 (48.6%) | 65/72 (90.3%) |
| Event | Radiation Therapy |
|---|---|
| dysphagiaGastrointestinal disorders | 14/72 |
| DehydrationMetabolism and nutrition disorders | 8/72 |
| AnorexiaMetabolism and nutrition disorders | 7/72 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 4/72 |
| nauseaGastrointestinal disorders | 4/72 |
| Lung infectionInfections and infestations | 3/72 |
| Acute kidney injuryRenal and urinary disorders | 2/72 |
| aspirationRespiratory, thoracic and mediastinal disorders | 2/72 |
| febrile neutropeniaBlood and lymphatic system disorders | 2/72 |
| hyponatremiaMetabolism and nutrition disorders | 2/72 |
| Event | Radiation Therapy |
|---|---|
| dysgeusiaNervous system disorders | 65/72 |
| OdynophagiaGastrointestinal disorders | 65/72 |
| Radiation dermatitisSkin and subcutaneous tissue disorders | 64/72 |
| DysphagiaGastrointestinal disorders | 63/72 |
| Weight lossInvestigations | 61/72 |
| dry mouthGastrointestinal disorders | 60/72 |
| FatigueGeneral disorders | 58/72 |
| Oral painGastrointestinal disorders | 56/72 |
| constipationGastrointestinal disorders | 55/72 |
| Sore throatRespiratory, thoracic and mediastinal disorders | 52/72 |
| Age, Continuous(years) | Radiation Therapy |
|---|---|
| Mean | 59.5 ± 10.9 |
| Sex: Female, Male(Participants) | Radiation Therapy |
|---|---|
| Female | 13 |
| Male | 59 |
| Race/Ethnicity, Customized(Participants) | Radiation Therapy |
|---|---|
| White | 58 |
| Black | 8 |
| Hispanic | 4 |
| Other | 2 |
| Region of Enrollment(participants) | Radiation Therapy |
|---|---|
| United States | 72 |
| Disease site(Participants) | Radiation Therapy |
|---|---|
| Oropharynx | 51 |
| Larynx | 21 |
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University of Texas Southwestern Medical Center