What is this study trying to find out about oral cavity cancer?

This study is evaluating whether sparing the surgical flap during post-operative radiotherapy can reduce treatment side effects while still effectively controlling the cancer locally. Researchers want to see if this approach is feasible and safe for patients with oral cavity cancer. The trial is sponsored by Centre Francois Baclesse.

Who may be eligible for this oral cavity cancer clinical trial?

Adults aged 18 or older with oral cavity cancer treated by reconstructive surgery involving a flap may be eligible. Patients must have good performance status and be candidates for post-operative radiotherapy. Those who have had prior head and neck radiotherapy or metastatic disease are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this oral cavity cancer clinical trial?

Study-related care, including radiotherapy and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06798922

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers a De-escalation Randomized Phase III Trial

Led by Centre Francois Baclesse · Updated on 2026-03-03

348

Participants Needed

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

This research focuses on patients with oral cavity cancer who have undergone reconstructive surgery involving a flap. The study aims to compare two types of post-operative radiotherapy to assess the feasibility of sparing surgical flaps from radiation. The goal is to reduce treatment toxicity while maintaining effective local control of the cancer. Participants will be randomly assigned to one of two groups the experimental group receiving post-operative radiotherapy with flap sparing, and the control group receiving standard post-operative radiotherapy without flap sparing, which is the current practice. Radiotherapy is delivered using Intensity-Modulated Radiation Therapy IMRT with photons or proton therapy IMPT. Both groups may also receive concurrent chemotherapy as part of their treatment. During the study, participants will be monitored for the primary outcome of loco-regional control rate measured two years after completing radiotherapy. Secondary outcomes include assessing the proportion of patients experiencing acute and late ear, nose, and throat ENT toxicities within 12 months after treatment. The study includes regular follow-ups to evaluate treatment effects and safety over time, with participation lasting through these assessment periods.

CONDITIONS

Brief Title

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient aged 18 years or older
Performance Status 0-2
Patient with oral cavity cancer treated by reconstructive surgery with a flap
Oropharynx cancer with flap extending into oral cavity may be included
Quality of resection with margins greater than 1 mm
Candidate for post-operative radiotherapy using IMRT or proton therapy
Concomitant chemotherapy allowed
Signed informed consent prior to any trial procedures
Affiliated to the social security system

You will not qualify if you...

Local flap too small to allow IMRT modulation
Prior radiotherapy to head and neck area
Metastatic disease
History of other cancer within 3 years except treated in-situ cervix or non-melanoma skin carcinoma
Participation in another clinical study that could interfere
Pregnant or lactating women
Unable or unwilling to comply with study requirements
Deprived of freedom or under guardianship

Research Team

Juliette THARIAT, Professor

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