Phase II Study of Lower-Dose Radiation Without Chemotherapy for Early-Stage HPV or p16-Positive Oropharyngeal Cancer

What this Trial Is About

Researchers are evaluating a treatment approach for patients with favorable prognosis Human Papillomavirus HPV or p16-positive oropharyngeal cancer. This research focuses on reducing the intensity of radiation therapy by omitting chemotherapy and lowering the radiation dose to the tumor and nearby areas at highest risk of cancer spread. The study aims to see if this adjusted treatment maintains cancer control while potentially reducing long-term side effects compared to the current standard combined chemotherapy and full-dose radiation therapy. The treatment being studied involves giving radiation therapy alone, with a total dose of 66 Gray Gy directed at the visible tumor. This approach excludes chemotherapy to assess if the cancer control remains effective with this lower intensity treatment. The study includes a single treatment group receiving this radiation-only therapy. Participants will be followed to measure several outcomes over two years, including progression-free survival, local and regional control of cancer, distant metastasis-free survival, overall survival, and quality of life. Additional evaluations include clinical and radiographic responses, rates of feeding tube placement, and neck dissection. Monitoring involves biopsies of active areas on PET-CT scans 3 to 4 months after treatment. The total study duration for participants includes these assessments and follow-up visits to track treatment effects and safety.

Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy