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Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

RecruitingPhase 3Ages 18 Years - anyAllCentre Francois Baclesse
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

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

30 sites
Chu Amiens
Amiens, France
Institut de Cancérologie de l'Ouest
Angers, France
Centre de la Baie
Avranches, France
Centre François Baclesse
Caen, France
CHU CAEN
Caen, France
Centre Hospitalier
Cherbourg, France
Centre Jean Perrin
Clermont-Ferrand, France
CHIC
Créteil, France

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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