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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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)
* Perioperative immunotherapy is allowed (neoadjuvant and/or adjuvant setting)
* 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 it's running

• Centre François Baclesse
  Caen, France Recruiting
• Chu Amiens
  Amiens, France Not yet recruiting
• Institut de Cancérologie de l'Ouest
  Angers, France Not yet recruiting
• Centre de la Baie
  Avranches, France Not yet recruiting
• Chu Caen
  Caen, France Not yet recruiting
• Centre Hospitalier
  Cherbourg, France Not yet recruiting

Study contacts

• Study coordinator: Juliette THARIAT, Professor
• Email: j.thariat@baclesse.unicancer.fr
• Phone: 33231455050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.