De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx

Study Overview
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Brief Summary
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This is a single-arm, observational registry study determining the effects of reduced radiation dose in select patients with human papillomavirus (HPV) positive oropharyngeal cancer.

Official Title
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De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx

Conditions
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HPV Positive Oropharyngeal Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: Intensity-Modulated Radiation Therapy (IMRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry. Numerous studies have demonstrated near 100% agreement between p16 and HPV for patients with oropharyngeal cancer. As such, the use of p16 has been accepted as an appropriate surrogate for HPV status. Clinical stage I, II, or III disease (AJCC Eighth Edition); Note: Patients with M1 tumors (distant metastases) are not eligible; History/physical examination within 6 weeks prior to registration, including assessment of weight and recent weight loss; Age ≥ 18; PET/CT within 6 weeks prior to registration; Patients must sign a study-specific informed consent form prior to study entry. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial. Exclusion Criteria: Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded; Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; Receipt of prior radiotherapy that would result in overlap with proposed field.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| De-escalated radiotherapy<br> | Radiation: Intensity-Modulated Radiation Therapy (IMRT)<br>* IMRT will be given in 30 daily fractions at 2 Gy per fraction (60 Gy total) beginning Day 1; Six fractions will be delivered per week. High risk patients will receive induction chemotherapy with 2 cycles of carboplatin and paclitaxel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-Year Progression-Free Survival | Progression-free survival (PFS) is defined as the time from registration to disease progression or death from any cause. | Given the natural history of this disease, PFS will be monitored up to 2 years from registration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Survival time will be measured from the date of randomization to the date of death due to any cause or last follow-up. | Given the natural history of this disease, overall survival will be monitored for up to 2 years from registration | 
| Local-regional control | Local-regional control is defined as the absence of local and/or regional progression. | Given the natural history of this disease, local-regional control will be monitored up to 2 years from registration |