Correlated Drug Terms (3)

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	Name (Synonyms)	Correlation
drug48	50 Gy Radiation Therapy Wiki	1.00
drug52	60 Gy Radiation Therapy Wiki	1.00
drug281	Atezolizumab Wiki	1.00

Correlated MeSH Terms (1)

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	Name (Synonyms)	Correlation
D006258	Head and Neck Neoplasms NIH	0.50

Correlated HPO Terms (1)

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	Name (Synonyms)	Correlation
HP:0012288	Neoplasm of head and neck HPO	0.50

Primary Outcomes

Description: This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.

Measure: Incidence of Dose-Limiting Toxicities

Time: 12 months

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Description: This measure is the highest radiation dose at which there is a 30% or more rate of dose-limiting toxicity up to 12 months after completion of radiation treatment using the TITE-CRM design.

Measure: Maximum Tolerated Radiation Dose

Time: 12 months

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Secondary Outcomes

Description: This measure is the number of subjects alive at 1 year following the conclusion of scheduled radiation therapy.

Measure: Overall Survival

Time: 1 year

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Description: This measure is the number of subjects showing disease progression in the head and neck by RECIST criteria.

Measure: Locoregional progression

Time: 1 year

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Description: This measure is the change in gross tumor volume for each subject as contoured on pre-treatment (baseline) and treatment 6 imaging scans.

Measure: Gross Tumor Volume at Radiation Fraction 6 (Change from Baseline)

Time: 6th Radiation Fraction (approximately 1 week)

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Description: This measure is the change in gross tumor volume for each subject as contoured on pre-treatment (baseline) and treatment 11 imaging scans.

Measure: Gross Tumor Volume at Radiation Fraction 11 (Change from Baseline)

Time: 11th Radiation Fraction (approximately 2 weeks)

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Description: MD Anderson Symptom Inventory for Head and Neck tool comprises 11-item Likert-style questions assessing 9 symptoms relevant to head and neck cancer. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').

Measure: MD Anderson Symptom Inventory for Head and Neck (MDASI-HN) Score

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "mucus in the mouth and throat" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to mucus in the mouth and throat. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').

Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Mucus in the Mouth and Throat)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "difficulty swallowing or chewing" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to swallowing or chewing. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').

Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Difficulty Swallowing or Chewing)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "choking or coughing" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to coughing or a sensation of choking. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').

Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Choking or Coughing)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "difficulty with voice or speech" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to voice production and quality or speech. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').

Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Difficulty with Voice or Speech)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "skin pain, burning or rash" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to the sensation of pain and/or burning and/or presence of a rash in irradiated areas of the skin. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').

Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Skin Pain, Burning or Rash)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "constipation" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to constipation and bowel function. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').

Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Constipation)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "problems with tasting food" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to the sensation of taste. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').

Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Problems with Tasting Food)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "mouth or throat sores" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to sores or lesions present in the mouth and throat. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').

Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Mouth or Throat Sores)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "problems with teeth or gums" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to oral health particularly the teeth and gums. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').

Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Problems with Teeth or Gums)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure comprises a single five-item, Likert-style question with responses ranging from 'Strongly Agree' to 'Strongly Disagree'. A higher score ('Strongly Agree') corresponds to a worse outcome.

Measure: MD Anderson Dysphagia Inventory Global Score

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure comprises 19 five-item, Likert-style questions with responses ranging from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') corresponds to worse traits or more severe symptoms.

Measure: MD Anderson Dysphagia Inventory Composite Score

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "emotional" domain comprising a subset of five-item, Likert-style questions of the MD Anderson Dysphagia Inventory Composite tool that assesses symptoms relevant to emotional health. Responses range from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') correspond to worse traits or more severe symptoms.

Measure: MD Anderson Dysphagia Inventory Score (Emotional)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "functional" domain comprising a subset of five-item, Likert-style questions of the MD Anderson Dysphagia Inventory Composite tool that assesses symptoms relevant to the ability to function in daily life activities. Responses range from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') correspond to worse traits or more severe symptoms.

Measure: MD Anderson Dysphagia Inventory Score (Functional)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: This measure is the score for the "physical" domain comprising a subset of five-item, Likert-style questions of the MD Anderson Dysphagia Inventory Composite tool that assesses symptoms relevant to the ability to perform physical activities. Responses range from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') correspond to worse traits or more severe symptoms.

Measure: MD Anderson Dysphagia Inventory Score (Physical)

Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1

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Description: The Eating Assessment Tool comprises 10 five-item, Likert-style questions querying various aspects of swallowing. Responses range from 0 (No problem) to 4 (Severe problem). The total of the responses represents the EAT-10 score. Higher numbers indicate poorer swallowing ability.

Measure: Eating Assessment Tool (EAT-10) Score

Time: Baseline, and months 3 and 6 following fraction 1

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Description: The Functional Oral Intake Scale is a clinician-completed ordinal rating scale ranging from 1 (No oral intake) to 7 (Total oral intake with no restrictions). Higher numbers indicate more favorable feeding capability.

Measure: Functional Oral Intake Scale (FOIS)

Time: Baseline, and months 3 and 6 following fraction 1

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Description: The DIGEST grade is a five-item modified barium swallow scale for grading pharyngeal dysphagia as a toxicity endpoint. The DIGEST grade responses are: grade 1= mild, grade 2= moderate, grade 3= severe, and grade 4= life threatening pharyngeal dysphagia.

Measure: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Grade

Time: Baseline, and months 3 and 6 following fraction 1

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HP:0012288: Neoplasm of head and neck

Genes 25

FOXE1 RHBDF2 SDHB KIT HABP2 SDHA KIT MINPP1 FH CTHRC1 APC SDHC RHBDF2 RAD21 STK11 ASCC1 PDGFRA STAT1 RNF6 APC TGFBR2 WWOX MSR1 RSPRY1 DLEC1

Protein Mutations 2

E10A P13K

SNP 2

rs11045585 rs12762549