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ClinicalTrials.gov ID

NCT06798922

Lead Sponsor

Centre Francois BaclesseOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

348Estimated

Last Update Posted

Jul 22, 2026Actual

Start Date

Mar 1, 2025Actual

Primary Completion Date

Mar 1, 2031Estimated

Completion Date

Mar 1, 2034Estimated

Official Title

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

Brief 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.

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

• Standard post-operative radiotherapy without flap sparing (current practice)
• Post-operative radiotherapy with flap sparing

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Patient aged 18 years or older
• Performance Status 0-2
• Patient with oral cavity cancer (soft tissue or soft tissue-bone flap), treated by reconstructive surgery with a flap. Oropharynx cancer whose flap extends significantly into the oral cavity may be included in the study
• Quality of resection with margins > 1 mm
• Patient candidate to post-operative radiotherapy (Intensity-Modulated Radiation Therapy (IMRT) or proton therapy)
• Concomitant chemotherapy is allowed (stratification parameter)
• Patient must have signed a written informed consent form prior to any trial specific procedures
• Patient affiliated to the social security system

Exclusion Criteria:

• Local flap (small size limiting IMRT modulation potential)
• History of radiotherapy of head and neck area
• Metastatic disease
• History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
• Simultaneous participation in another clinical study may compromise the conduct of this study.
• Pregnant or lactating women
• Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
• Patient deprived of freedom or under guardianship

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Francois BaclesseOTHER

veyssiere-a@chu-caen.fr

soumya.anane@chicreteil.fr0157022700

ebrenet@chu-reims.fr

sophie.deneuve@chu-rouen.fr

piram.lucie@iuct-oncopole.fr