Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

• Status: Not yet recruiting
• Trial end date: 2030-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heath Skinner
• Treatments: Carboplatin

Criteria

Inclusion Criteria:

• ECOG performance status of 0 or 1.

• Newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx and resectable oropharyngeal disease.

• American Joint Committee on Cancer (AJCC, 7th edition (used as a direct comparison to ECOG 3311)) TNM tumor stage III, IV a, or IV b (with no evidence of distant metastases) as determined by imaging studies (performed < 30 days prior to registration) and complete neck exam, from the skull base to the clavicles.

• 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.

• 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, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancer.

• Patients with congestive heart failure > NYHA Class II, CVA/TIA, unstable angina, or myocardial infarction within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist.

• Acceptable renal and hepatic function within 4 weeks prior to registration as predefined.

Exclusion Criteria:

• No evidence of extensive or "matted/fixed" pathologic adenopathy on preoperative imaging.

• Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy.

• No intercurrent illness likely to interfere with protocol therapy or prevent surgical resection.

• No uncontrolled diabetes, infection despite antibiotics, or hypertension within 30 days prior to registration.