Phase II Study of Lower-Dose Radiation and Smaller Treatment Area After Surgery for HPV-Positive Oropharyngeal Cancer

What this Trial Is About

Researchers are evaluating whether patients with intermediate-risk HPV or p16 positive oropharyngeal cancer, who have had Transoral Robotic Surgery and minimal smoking history, can safely receive a lower radiation dose targeted only to the neck instead of the original tumor site. The study aims to see if reducing radiation dose and limiting the treatment area leads to similar tumor control compared to standard radiation therapy. This approach may improve quality of life by reducing treatment side effects. Participants will receive a lower than standard radiation dose of 50 Gy in 25 fractions using either Intensity Modulated Radiation Therapy IMRT or proton beam therapy. The radiation will be focused solely on the neck, excluding the primary tumor site in the oropharynx. This de-escalation approach contrasts with the usual 60 Gy dose to both the primary site and neck. The study is a phase II trial and builds on previous research showing success with dose reduction and omission of chemotherapy in similar patients. During the study, participants will be closely monitored through various assessments including tumor progression, quality of life measures, and survival outcomes over two years. Researchers will track progression-free survival as the primary outcome along with local and regional cancer control, distant metastasis-free survival, overall survival, and the rate of feeding tube placement. Study visits include clinical evaluations, imaging, and laboratory tests. Participation may last for several years with ongoing follow-up to evaluate long-term effects and safety.

De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers