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Completed

NCT Number: NCT03715946

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

This clinical trial will evaluate a new combination of treatments for Oropharyngeal Squamous Cell cancers (OPSCC), and compare it to the current standard of care (concurrent, platinum-based chemoradiotherapy). Chemoradiotherapy is efficacious, but also associated with significant toxicities and is only suitable for patients with good performance status and without severe comorbidities. The purpose of this trial is to demonstrate equivalent oncologic outcome with fewer adverse effects and improved quality of life when compared to the standard of care.

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Key information

Conditions

Carcinoma, Squamous Cell of Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Oropharyngeal Neoplasms Oropharynx Squamous Cell Carcinoma Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Winship Cancer Institute @ Emory University Hospital Midtown, Atlanta, Georgia, United States

Loading trial locations.

About this study

This study aims to enroll 135 patients (male and female, age 18+) who are newly diagnosed with resectable, squamous cell carcinoma or undifferentiated carcinoma of the oropharynx. Survival rate and treatment response of OPSCC varies based on HPV infection status and genotype; therefore, in this study, only patients who are HPV seropositive and have HPV type 16 will be enrolled. All patients will receive the same treatment, i.e. there is no active control group.

In this trial, patients will undergo transoral surgery followed by de-intensified adjuvant radiotherapy plus nivolumab. The radiotherapy will consist of 45 or 50 Gy (depending on tumor volume) in 25 daily fractions, 6 fractions per week. Nivolumab will be administered at a fixed dose of 240 mg over 30 minutes IV every 2 weeks during radiotherapy, and at 480 mg over 60 minutes IV every 4 weeks for 6 doses after radiotherapy. The first dose will be given prior to the first fraction of radiation (Day 1) on Day -3 (+/- 2 days), and continued every 2 weeks (+/- 2 days). Nivolumab will thus be given in weeks 2 and 4 of radiotherapy. Adjuvant nivolumab will then be given for a total of 6 additional doses after the completion of radiotherapy every 4 weeks (+/- 7 days), starting in the second or third week after the completion of radiotherapy. Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment. Relevant outcome measures include disease free survival (2 year post surgery); percutaneous gastronomy dependence (1-year postsurgery); acute and late toxicity; patient-reported Quality of Life measures, locoregional control and distant metastatic control.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >/= 18 years.
  • ECOG performance status of 0 or 1.
  • Patients must have newly diagnosed, histologically or cytologically confirmed squamous cell carcinoma or undifferentiated carcinoma of the oropharynx. Patients must have been determined to have resectable oropharyngeal disease. Patients with primary tumor or nodal metastasis fixed to the carotid artery, skull base or cervical spine are not eligible.
  • Patients must have intermediate risk factors, as described below as determined by imaging studies (performed < 45 days prior to registration) and complete neck exam, from the skull base to the clavicles. The following imaging is required: CT scan of neck only with IV contrast or MRI. PET scan of HN and chest with IV contrasted CT correlation is encouraged prior to enrollment.

Intermediate risk features: Tobacco <10 pk-yr: T0-3 plus any one of the following: >N2b (> 5 LN's +), N2c/N3, +ENE >1 mm, or + margin (if approved by surgical chair) OR Tobacco >10 pk-yr: T0-3 plus any one of the following: any N2, N3, +ENE >1 mm, or + margin (if approved by surgical chair)

  • Patients must have no evidence of distant metastases (M0)
  • Patients must have biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node. It is required that patients have a positive p16 IHC (as surrogate for HPV) status from either the primary tumor or metastatic lymph node.
  • Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory.
  • No prior radiation above the clavicles.
  • Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, differentiated thyroid cancer, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancer, or clinically negligible in judgement of investigator.
  • Patients with the following within the last 6 months prior to registration must be evaluated by a cardiologist and / or neurologist prior to entry into the study.
  • Congestive heart failure > NYHA Class II
  • CVA / TIA
  • Unstable angina
  • Myocardial infarction (with or without ST elevation)
  • Patients must have acceptable renal and hepatic function within 4 weeks prior to registration as defined below:
  • Absolute neutrophil count ≥1,500/mm3
  • Platelets ≥ 100,000/mm3
  • Total bilirubin ≤ the upper limit of normal (ULN)
  • Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula: (140-age)*wt(kg)/([Cr]*72). For women the calculation should be multiplied by 0.85
  • Women must not be pregnant or breast-feeding. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Patient without intercurrent illness likely to interfere with protocol therapy.
  • Patients must not have uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension within 30 days prior to registration.

Exclusion criteria

  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 30 days of first administration of study treatment (subjects with prior radiation, cytotoxic or investigational products < 4 weeks prior to treatment might be eligible after discussion between investigator and sponsor, if toxicities from the prior treatment have been resolved to Grade 1 (NCI CTCAE version 4).
  • Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. Subjects who test positive for HCV antibody but negative for HCV ribonucleic acid are permitted to enroll.
  • Known history of testing positive for human immunodeficiency virus (HIV) and CD4 count < 200 or known acquired immunodeficiency syndrome (AIDS).
  • Any Grade 4 laboratory abnormalities.
  • History of allergy to study drug components.
  • History of severe hypersensitivity reaction to any human monoclonal antibody.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Treatment and study plan

Nivolumab Injection

Drug

A fully human anti-programmed death 1 (PD-1) monoclonal antibody

Other names: BMS-936558

Radiotherapy (RT)

Radiation

45-50 Gy accelerated fractionation in 25 daily fractions, 6 fractions per week

Primary outcomes

  1. One-year Progression-free Survival (PFS)

    Time frame: At 1 year post start of treatment

    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.

  2. Two-year Progression-free Survival (PFS)

    Time frame: At 2 years post start of treatment

    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.

  3. PEG Tube Dependence

    Time frame: At 1-year post-surgery

    Presence /absence of enteral feeding tube.

Secondary outcomes

  1. Worst Grade of Adverse Events Related to Treatment

    Time frame: Up to 24 months

    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

  2. Local Recurrence-free Survival (RFS) at One Year

    Time frame: At 1-year post-surgery

    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.

  3. Local Recurrence-free Survival (RFS) at Two Years

    Time frame: At 2-years post-surgery

    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.

  4. Regional Recurrence-free Survival (RFS)

    Time frame: At one year post surgery

    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.

  5. Regional Recurrence-free Survival (RFS)

    Time frame: At two years post-surgery

    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.

  6. Distant Recurrence-free Survival (RFS) at One Year

    Time frame: At one year post-surgery

    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.

  7. Distant Recurrence-free Survival (RFS)

    Time frame: At 2 years post-surgery

    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.

  8. Overall Survival (OS) at One Year

    Time frame: At one year

    The probability of survival from the start of treatment.

  9. Overall Survival (OS) at Two Years

    Time frame: At two years

    The probability of survival from the start of treatment.

  10. MD Anderson Dysphagia Inventory (MDADI)

    Time frame: At baseline

    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.

  11. MD Anderson Dysphagia Inventory (MDADI)

    Time frame: At 3 months after 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.

  12. MD Anderson Dysphagia Inventory (MDADI)

    Time frame: At 6 months after 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.

  13. MD Anderson Dysphagia Inventory (MDADI)

    Time frame: At 9 months after 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.

  14. MD Anderson Dysphagia Inventory (MDADI)

    Time frame: At 12 months after 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.

  15. MD Anderson Dysphagia Inventory (MDADI)

    Time frame: At 18 months after 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.

  16. MD Anderson Dysphagia Inventory (MDADI)

    Time frame: At 21 months after 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.

  17. MD Anderson Dysphagia Inventory (MDADI)

    Time frame: At 24 months after 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.

  18. MD Anderson Dysphagia Inventory (MDADI)

    Time frame: At 30 months after 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.

  19. MD Anderson Dysphagia Inventory (MDADI) (Total - Overall Score)

    Time frame: Up to 30 months after start of treatment

    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.

  20. Voice Handicap Index-10 (VHI-10)

    Time frame: At baseline

    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.

  21. Voice Handicap Index-10 (VHI-10)

    Time frame: At 3 months after completion of treatment

    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.

  22. Voice Handicap Index-10 (VHI-10)

    Time frame: At 6 months after completion of treatment

    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.

  23. Voice Handicap Index-10 (VHI-10)

    Time frame: At 9 months after completion of treatment

    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.

  24. Voice Handicap Index-10 (VHI-10)

    Time frame: At 12 months after completion of treatment

    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.

  25. Voice Handicap Index-10 (VHI-10)

    Time frame: At 18 months after completion of treatment

    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.

  26. Voice Handicap Index-10 (VHI-10)

    Time frame: At 21 months after completion of treatment

    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.

  27. Voice Handicap Index-10 (VHI-10)

    Time frame: At 24 months after completion of treatment

    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.

  28. Voice Handicap Index-10 (VHI-10)

    Time frame: At 30 months after completion of treatment

    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.

  29. Voice Handicap Index-10 (VHI-10) (Total)

    Time frame: Calculated at 30 months after completion of treatment

    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.

  30. Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score

    Time frame: At baseline (prior to treatment)

    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.

  31. Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score

    Time frame: At 3 months after start of treatment

    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.

  32. Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score

    Time frame: At 6 months after start of treatment

    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.

  33. Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score

    Time frame: At 9 months after start of treatment

    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.

  34. Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score

    Time frame: At 12 months after start of treatment

    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.

  35. Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score

    Time frame: At 18 months after start of treatment

    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.

  36. Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score

    Time frame: At 21 months after completion of treatment

    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.

  37. Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score

    Time frame: At 24 months after start of treatment

    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.

  38. Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score

    Time frame: At 30 months after start of treatment

    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.

  39. Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total)

    Time frame: Calculated at 30 months after start of treatment

    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.

  40. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

    Time frame: At baseline

    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.

  41. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

    Time frame: At 3 months after start of treatment

    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.

  42. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

    Time frame: At 6 months after start of treatment

    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.

  43. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

    Time frame: At 9 months after start of treatment

    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.

  44. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

    Time frame: At 12 months after start of treatment

    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.

  45. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

    Time frame: At 18 months

    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.

  46. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

    Time frame: At 21 months after start of treatment

    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.

  47. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

    Time frame: At 24 months after start of treatment

    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.

  48. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

    Time frame: At 30 months after start of treatment

    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.

  49. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) (Total)

    Time frame: Calculated at 30 months after start of treatment

    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.

  50. Modified Barium Swallow (MBS) Rating

    Time frame: At 6 and 24 months after completion of treatment

    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.

  51. Performance Status Scale (PSS-HN)

    Time frame: At 3, 6, 12 and 24 months after completion of treatment

    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.

  52. EuroQoL-5D Questionnaire

    Time frame: At baseline

    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.

  53. EuroQoL-5D Questionnaire

    Time frame: At 3 months after start of treatment

    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.

  54. EuroQoL-5D Questionnaire

    Time frame: At 6 months after start of treatment

    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.

  55. EuroQoL-5D Questionnaire

    Time frame: At 9 months after start of treatment

    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.

  56. EuroQoL-5D Questionnaire

    Time frame: At 12 months after start of treatment

    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.

  57. EuroQoL-5D Questionnaire

    Time frame: At 18 months after start of treatment

    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.

  58. EuroQoL-5D Questionnaire

    Time frame: At 21 months after start of treatment

    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.

  59. EuroQoL-5D Questionnaire

    Time frame: At 24 months after start of treatment

    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.

  60. EuroQoL-5D Questionnaire

    Time frame: At 30 months after start of treatment

    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.

  61. EuroQoL-5D Questionnaire (Total)

    Time frame: Calculated at 30 months after start of treatment

    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.

Other outcomes

  1. Tumor TP53 Mutation

    Time frame: At baseline prior to treatment; Up to 5 years

    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.

  2. Determination of Tumor Genomics

    Time frame: At baseline prior to treatment; Up to 5 years

    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.

  3. Presence of Plasma Cytokines

    Time frame: At baseline prior to treatment; Up to 5 years

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

  4. Antigen-specific Immune Response to Human Papillomavirus (HPV)

    Time frame: At baseline prior to treatment; Up to 5 years

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

  5. Determination of Oral Human Papillomavirus (HPV) DNA

    Time frame: At baseline prior to treatment

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

Sponsors and collaborators

Lead sponsor

Robert L. Ferris, MD, PhD

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Phase II Trial of Adjuvant De-Escalated Radiation + Concurrent and Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Oct 23, 2018
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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