Trial Outcomes & Findings for Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer (NCT NCT03715946)

Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer

The probability of PFS measured from of beginning of study treatment, without local, regional or distant disease recurrence (appearance of new metastatic lesions). Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.

The probability of PFS measured from of beginning of study treatment, without local, regional or distant disease recurrence (appearance of new metastatic lesions). Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.

Presence /absence of enteral feeding tube.

Number of patients experiencing Adverse Events and Serious Adverse Events (SAE) related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Probability of patients with disease growth that is not present within the area in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.

Probability of patients with disease growth that is not present within the area in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.

Probability of patients with disease growth that is not present within the anatomical region in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.

Probability of patients with disease growth that is not present within the anatomical region in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.

Probability of patients with disease that has spread (metastasized) to areas farther away from where disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.

Percentage of patients with disease that has spread (metastasized) to areas farther away from where disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.

The probability of survival from the start of treatment.

The probability of survival from the start of treatment.

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.

Total scores including all time-points for the MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function. Scores taken at month 3, 6, 12, 24 and 30 months after completion of treatment were averaged for the population and reported below.

The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.

The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.

The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.

The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.

The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.

The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.

The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.

The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.

The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.

Total scores are a mean average of time-points for the VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.

The FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life. Total scores as mean average of the combined participant values.

The FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.

The FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.

The FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.

The FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.

The FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.

The FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.

The FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.

The FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.

Total scores as mean average of the combined timepoint values for the FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.

MDASI-HN measures treatment related symptom burden in head and neck cancer patients. The 20-item MDASI measures both severity and burden of symptoms and their effect on patients' daily activities, using a numeric rating scale of 0-10. This instrument includes 13 core symptoms and 9 head and neck specific items. Higher scores indicate superior perception of function.

MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.

MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.

MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.

MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.

MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.

MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.

MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.

MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.

Total scores as mean average of the combined timepoint values. Includes all time-points for MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in mouth and difficulty swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale).Total scores range 0-280;higher scores mean better life quality.

Three swallowing outcomes will be rated by the SLP conducting the MBS study and reported by research staff: 1) laryngeal penetration (yes, no); 2) aspiration (no, sensate, silent), and 3) pharyngeal residue (no, \< 50%, \> 50%). These have been selected as universal items generally reported by swallowing clinicians that have been shown to significantly predict pneumonia in patients with oropharyngeal cancers. Prevalence of these dysphagia endpoints will be estimated at each time point.

The Performance Status Scale (PSS-HN) is a clinician-rated instrument consisting of 3 questions: normalcy of diet, public eating/swallowing, and understandability of speech subscales in patients with head and neck cancer. Each subscale is rated from 0 to 100, with higher scores indicating better performance.

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

Total scores as mean average of the combined timepoint values for the EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

Determination of tumor TP53 mutation as measured in serum and/or tissue samples. The presence of TP53 mutations results in a protein that is less able to control cell proliferation as it is unable to trigger apoptosis in cells with damaged DNA.

Determination of tumor genomics, measured in serum and/or tissue samples. This measure will explore the of DNA sequence and gene expression differences in tumor cells and gene abnormalities may that drive the drives disease growth.

Determination of cytokines present in plasma samples. The presence of cytokines in tissues can associated positively or negatively in the development of disease.

Determination of antigen-specific cellular immune response to Human papillomavirus (HPV) measured in serum and/or tissue samples.

Determination of oral HPV DNA present/measured in oral tissue samples.