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Elective nodal irradiation has been a longstanding standard-of-care in the management of mucosal squamous cell carcinoma of the head and neck. Recent studies have suggested that reduced elective dose and volume may be a viable approach to improve toxicity. In this study, we are eliminating the elective neck treatment, focusing therapy on involved and suspicious nodes.
We recently completed and reported a successful study (INFIELD) using reduced elective dose (40 Gy) and volume (involved echelons + 1) for oropharynx and larynx cancer. In INRT-AIR (Involved Nodal Radiotherapy using AI-based Radiomics), we are eliminating the elective neck treatment altogether, using radiologic and radiomic-based criteria to focus treatment on the nodes themselves. Eligible patients include previously untreated patients with stage I-IVB oropharynx, larynx and hypopharynx cancer, excluding T1-2 glottic carcinoma. Patients requiring chemotherapy may receive cisplatin, cetuximab, or carboplatin-paclitexel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET-CT at 3 months and ENT evaluation | Experimental | Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity modulated radiation therapy (IMRT) | Radiation | Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT | Definition: solitary means that the recurrence occurred without a preceding or synchronous in-field or distant recurrence By definition, local recurrence (LR) means disease recurrence in the primary site, and regional recurrence (RR) is a nodal failure anywhere in the neck. Patients who experienced either an LR or RR (or both), were also coded as a locoregional recurrence. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of SEVR Risks by Anatomic Site | OS= Overall survival PFS= Progression-free survival | 2 years |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales |
Not provided
Inclusion Criteria:
Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (< 2 nodes) is also allowable.
Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
Age ≥ 18 years.
ECOG Performance Status 0-2
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.
7.1 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:
Negative serum pregnancy test within 2 weeks before registration for women of childbearing potential.
Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh).
Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Sher, MD, MPH | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | INRT | Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | INRT | Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT | Definition: solitary means that the recurrence occurred without a preceding or synchronous in-field or distant recurrence By definition, local recurrence (LR) means disease recurrence in the primary site, and regional recurrence (RR) is a nodal failure anywhere in the neck. Patients who experienced either an LR or RR (or both), were also coded as a locoregional recurrence. | Posted | Number | percentage of participants | 2 years |
|
3 years
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INRT | Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Sher, MD | University of Texas Southwestern Medical Center | (214)645-7607 | david.sher@utsouthwestern.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2020 | Oct 14, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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The EORTC QLQ-C30 is a 30-item instrument (30 questions). Results are calculated from the means of the scores from the summary score and the functional QLQ-C30 scales. Higher scores indicate better quality of life, on a scale from 0 to 100.
Patients answer questions that are grouped into the following scales:
Summary score (scored from 0-100, with higher scores indicating a better quality of life)
-Global (Patients rate overall health and quality of life)
Functional scales (each of these is scored from 0-100, with higher scores indicating a better quality of life)
| Baseline, 3 months, 6 months, 12 months, 24 months |
| European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales | Patients report to which extent they experience symptoms or problems during one week. EORTC HN35 subscales are each scored on a scale from 0 to 100, with higher scores indicating worse symptoms. These subscales include dry mouth, sticky saliva, senses (taste/smell), pain, and speech issues | Baseline, 3 month, 6 month, 12 month, 24 months |
| MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales | Questionnaire asks for patients' views about swallowing ability. MDADI scores range from 20 to 100, where higher scores represent better swallowing ability. | Baseline, 3 months, 6 months, 12 months, 24 months |
| Skin Toxicity (Dermatitis) | According to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria Higher grades indicate worse adverse events. This is assessed clinically by the patient's physician. Grade 1 is defined as "Faint erythema or dry desquamation" Grade 2 is defined as "Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema" Grade 3 is defined as "Moist Desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion" | 2 years |
| Gastrostomy Placement | Number of patients who experienced gastrostomy dependence for a period of time following treatment with INRT up to 2 years post treatment | from end of treatment to 2 years post treatment |
| EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS) | Average patient utilities (derived from EQ-5D) at baseline, 1, 3, 6, 12, 18, 24 and 36 months from the end of treatment. The overall health VAS is scored from 0 (worst imaginable health) to 100 (best imaginable health) based on the patient's self-reported health that day. | Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months from the end of treatment |
| 2-year Overall and Progression-free Survival Following Treatment With INRT | Overall survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death. Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death. | 2 years |
| Time From the End of Treatment for Disease-free Patients to Have Their Gastrostomy Tubes Removed | Median length of gastrostomy dependence following treatment with INRT for patients who had needed a gastrostomy tube inserted and who were deemed disease-free | 2 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Disease Site | Count of Participants | Participants |
|
|
|
| Secondary | Comparison of SEVR Risks by Anatomic Site | OS= Overall survival PFS= Progression-free survival | 48 patients were analyzed for oropharynx disease site; 19 patients were analyzed for larynx/hypopharynx disease site | Posted | Number | percentage probability of 2-year OS/PFS | 2 years |
|
|
|
| Secondary | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales | The EORTC QLQ-C30 is a 30-item instrument (30 questions). Results are calculated from the means of the scores from the summary score and the functional QLQ-C30 scales. Higher scores indicate better quality of life, on a scale from 0 to 100. Patients answer questions that are grouped into the following scales: Summary score (scored from 0-100, with higher scores indicating a better quality of life) -Global (Patients rate overall health and quality of life) Functional scales (each of these is scored from 0-100, with higher scores indicating a better quality of life)
| Posted | Mean | Standard Error | score on a scale | Baseline, 3 months, 6 months, 12 months, 24 months |
|
|
|
| Secondary | European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales | Patients report to which extent they experience symptoms or problems during one week. EORTC HN35 subscales are each scored on a scale from 0 to 100, with higher scores indicating worse symptoms. These subscales include dry mouth, sticky saliva, senses (taste/smell), pain, and speech issues | Posted | Mean | Standard Error | score on a scale | Baseline, 3 month, 6 month, 12 month, 24 months |
|
|
|
| Secondary | MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales | Questionnaire asks for patients' views about swallowing ability. MDADI scores range from 20 to 100, where higher scores represent better swallowing ability. | Posted | Mean | Standard Error | score on a scale | Baseline, 3 months, 6 months, 12 months, 24 months |
|
|
|
| Secondary | Skin Toxicity (Dermatitis) | According to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria Higher grades indicate worse adverse events. This is assessed clinically by the patient's physician. Grade 1 is defined as "Faint erythema or dry desquamation" Grade 2 is defined as "Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema" Grade 3 is defined as "Moist Desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion" | Posted | Number | percentage of patients with toxicity | 2 years |
|
|
|
| Secondary | Gastrostomy Placement | Number of patients who experienced gastrostomy dependence for a period of time following treatment with INRT up to 2 years post treatment | Posted | Count of Participants | Participants | from end of treatment to 2 years post treatment |
|
|
|
| Secondary | EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS) | Average patient utilities (derived from EQ-5D) at baseline, 1, 3, 6, 12, 18, 24 and 36 months from the end of treatment. The overall health VAS is scored from 0 (worst imaginable health) to 100 (best imaginable health) based on the patient's self-reported health that day. | Posted | Mean | Full Range | score on a scale | Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months from the end of treatment |
|
|
|
| Secondary | 2-year Overall and Progression-free Survival Following Treatment With INRT | Overall survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death. Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death. | Posted | Number | percentage probability of 2-year OS/PFS | 2 years |
|
|
|
| Secondary | Time From the End of Treatment for Disease-free Patients to Have Their Gastrostomy Tubes Removed | Median length of gastrostomy dependence following treatment with INRT for patients who had needed a gastrostomy tube inserted and who were deemed disease-free | disease-free patients who had their g-tubes removed | Posted | Median | Inter-Quartile Range | months from end of treatment | 2 years |
|
|
|
| 1 |
| 67 |
| 12 |
| 67 |
| 67 |
| 67 |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Altered Mental Status | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypervolemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Laryngeal Edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Localized Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Trach Replacement | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic Event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphedema | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hearing loss | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Covid-19 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Polydipsia | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Salivary duct inflammation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thick secretions | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrush | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| WBC count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
|
| PFS Oropharynx |
|
|
| PFS Larynx/hypopharynx |
|
|
| Title | Measurements |
|---|---|
|
| Global 12M |
|
| Global 24M |
|
| Physical fcn baseline |
|
| Physical fcn 3M |
|
| Physical fcn 6M |
|
| Physical fcn 12M |
|
| Physical fcn 24M |
|
| Role fcn baseline |
|
| Role fcn 3M |
|
| Role fcn 6M |
|
| Role fcn 12M |
|
| Role fcn 24M |
|
| Emotional fcn baseline |
|
| Emotional fcn 3M |
|
| Emotional fcn 6M |
|
| Emotional fcn 12M |
|
| Emotional fcn 24M |
|
| Cognitive fcn baseline |
|
| Cognitive fcn 3M |
|
| Cognitive fcn 6M |
|
| Cognitive fcn 12M |
|
| Cognitive fcn 24M |
|
| Social fcn baseline |
|
| Social fcn 3M |
|
| Social fcn 6M |
|
| Social fcn 12M |
|
| Social fcn 24M |
|
| Title | Measurements |
|---|---|
|
| HN35 Dry Mouth 12M |
|
| HN35 Dry Mouth 24M |
|
| HN35 Sticky Saliva Baseline |
|
| HN35 Sticky Saliva 3M |
|
| HN35 Sticky Saliva 6M |
|
| HN35 Sticky Saliva 12M |
|
| HN35 Sticky Saliva 24M |
|
| HN35 Senses Baseline |
|
| HN35 Senses 3M |
|
| HN35 Senses 6M |
|
| HN35 Senses 12M |
|
| HN35 Senses 24M |
|
| HN35 Pain Baseline |
|
| HN35 Pain 3M |
|
| HN35 Pain 6M |
|
| HN35 Pain 12M |
|
| HN35 Pain 24M |
|
| HN35 Speech Baseline |
|
| HN35 Speech 3M |
|
| HN35 Speech 6M |
|
| HN35 Speech 12M |
|
| HN35 Speech 24M |
|
| Title | Measurements |
|---|---|
|
| Composite MDADI 12M |
|
| Composite MDADI 24M |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| 6M |
|
| 12M |
|
| 18M |
|
| 24M |
|
| 36M |
|