Phase III Trial Comparing Flap Sparing Versus Standard Postoperative Radiotherapy in Oral Cavity Cancer Patients After Reconstructive Surgery

What this Trial Is About

This trial involves patients with oral cavity cancer who have undergone reconstructive surgery using a flap. It aims to evaluate whether sparing the surgical flap during post-operative radiotherapy can reduce treatment toxicity while still maintaining local disease control. The study is a randomized Phase III trial comparing two radiotherapy approaches. Participants are assigned to one of two groups the experimental group receives post-operative radiotherapy that spares the surgical flap, while the control group receives standard post-operative radiotherapy without flap sparing. Radiotherapy is delivered using intensity-modulated radiation therapy IMRT with photons or proton therapy IMPT. The goal is to assess the feasibility and impact of flap-sparing radiotherapy versus current standard practice. During the study, participants will be monitored for local-regional cancer control up to two years after radiotherapy. Researchers will also evaluate the occurrence of acute and late ear, nose, and throat ENT toxicities within 12 months following treatment. Participants must have performance status 0-2 and be candidates for post-operative radiotherapy. The total study duration extends through treatment and follow-up, with safety and disease control assessments conducted throughout.

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers