Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers (OPTIFLAP)

March 2, 2026 updated by: Centre Francois Baclesse

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

348

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
      • Angers, France
      • Caen, France
      • Caen, France
      • Clermont-Ferrand, France
      • Créteil, France
      • Dijon, France
        • Not yet recruiting
        • Centre Georges-François Leclerc
        • Contact:
          • Noémie VULQUIN, MD
      • Le Havre, France
        • Not yet recruiting
        • Centre Guillaume Le Conquerant
        • Contact:
          • Laurent MARTIN, MD
      • Libourne, France
      • Lille, France
      • Lyon, France
      • Marseille, France
        • Not yet recruiting
        • APHM Marseille
        • Contact:
          • Stéphanie WONG-HEE-KAM, MD
      • Montpellier, France
        • Not yet recruiting
        • Institut Régional du Cancer Val D'aurelle
        • Contact:
          • Pierre BOISSELIER, MD
      • Nancy, France
      • Nice, France
        • Not yet recruiting
        • Centre Antoine Lacassagne
        • Contact:
          • Deborah ALOI, MD
      • Paris, France
      • Poitiers, France
      • Reims, France
      • Rennes, France
      • Rouen, France
      • Rouen, France
      • Saint-Herblain, France
      • Toulouse, France
      • Tours, France
        • Not yet recruiting
        • CHU Tours
        • Contact:
          • Sofia BAKKAR, MD
      • Villejuif, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard arm
Standard IMRT or proton therapy practice, usual CTV definition
Radiation: Standard post-operative radiotherapy without flap sparing (current practice)
Standard post-operative radiotherapy without flap sparing (current practice)
Experimental: Experimental arm
IMRT or proton therapy with flap sparing
Radiation: Post-operative radiotherapy with flap sparing
Post-operative radiotherapy with flap sparing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
loco-regional control rate
Time Frame: 2 years after the end of postoperative radiotherapy
To evaluate whether flap sparing yields non-inferior 2-year loco-regional control rate as flap-agnostic radiotherapy (as per standard routine practice) in completely resected oral cavity carcinomas undergoing postoperative radiotherapy
2 years after the end of postoperative radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities
Time Frame: within 12 months after postoperative radiotherapy
Rate of Ear-Nose-Throat (ENT) toxicities among cavity cancer patients with a flap, defined as the proportion of oral cavity cancer patients with at least two ENT toxicities grade ≥ 2 according to NCI-CTCAE v5.0
within 12 months after postoperative radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2034

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A01764-43

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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