NCT06798922

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (estimated)
• Sponsor: Centre Francois Baclesse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with oral cavity cancer treated by reconstructive surgery with a flap. Patients will be treated in the study for : * Experimental arm: Post-operative radiotherapy with flap sparing * Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT)

Detailed description

Patients with oral cavity cancer treated by reconstructive surgery with a flap. Patients will be treated in the study for : * Experimental arm: Post-operative radiotherapy with flap sparing * Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT) Our purpose is to demonstrate the feasibility of sparing surgical flaps from radiotherapy, in order to reduce toxicity while maintaining local disease control.

Conditions

• Oral Cavity Carcinoma
• Flap
• Radiotherapy, Adjuvant
• Reconstruction Surgery

Interventions

Type	Name	Description
RADIATION	Standard post-operative radiotherapy without flap sparing (current practice)	Standard post-operative radiotherapy without flap sparing (current practice)
RADIATION	Post-operative radiotherapy with flap sparing	Post-operative radiotherapy with flap sparing

Timeline

• Start date: 2025-03-01
• Primary completion: 2031-03-01
• Completion: 2034-03-01
• First posted: 2025-01-29
• Last updated: 2026-03-03

Locations

25 sites across 1 country: France