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Sparing reconstructive flaps during post‑operative radiotherapy for oral cavity cancer

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

Phase 3 Interventional Centre Francois Baclesse · NCT06798922

This trial tests whether shielding reconstructive surgical flaps during post‑operative radiotherapy reduces treatment side effects for adults treated for oral cavity cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment348 (estimated)
Ages18 Years and up
SexAll
SponsorCentre Francois Baclesse Academic / other
Drugs / interventionschemotherapy, Radiation
Locations25 sites (Amiens and 24 other locations)
Trial IDNCT06798922 on ClinicalTrials.gov

What this trial studies

This phase 3 randomized trial compares post‑operative radiotherapy that intentionally spares reconstructive flaps with standard post‑operative radiotherapy that does not. Radiotherapy is delivered by IMRT with photons or by intensity‑modulated proton therapy (IMPT), and concomitant chemotherapy is permitted when clinically indicated. The trial aims to demonstrate the feasibility of flap‑sparing to reduce radiation‑related toxicity while maintaining local disease control. Eligible participants are adults who underwent resection and reconstruction with a soft tissue or soft tissue‑bone flap and have surgical margins greater than 1 mm.

Who should consider this trial

Good fit: Adults (≥18 years) with oral cavity cancer who had reconstructive surgery with a soft tissue or soft tissue‑bone flap, have margins >1 mm, a performance status of 0–2, and are candidates for post‑operative IMRT or IMPT are ideal candidates.

Not a fit: Patients with very small local flaps that limit modulation, prior head and neck radiotherapy, metastatic disease, or recent other malignancies are unlikely to benefit from the flap‑sparing approach.

Why it matters

Potential benefit: If successful, the approach could reduce radiation injury to the flap and surrounding tissues, lowering side effects while keeping cancer control intact.

How similar studies have performed: Organ‑ or structure‑sparing radiation techniques (for example salivary gland sparing) have reduced toxicity in head‑and‑neck cancer, but targeted flap‑sparing is relatively novel with limited prior data.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Amiens and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Oral Cavity CarcinomaFlapRadiotherapy, AdjuvantReconstruction Surgeryprotontherapyflaporal cavity carnicomaradiotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.