RecruitingPhase 3NCT06798922

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

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


Sponsor

Centre Francois Baclesse

Enrollment

348 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether the skin flap used to reconstruct the mouth after oral cavity cancer surgery can be "spared" (excluded) from the radiation field during post-surgical radiotherapy. Sparing the flap from radiation could reduce complications like tissue death or poor healing while still treating the cancer effectively. **You may be eligible if...** - You are 18 or older - You have oral cavity cancer (or oropharynx cancer with a flap extending into the oral cavity) - You had reconstructive surgery with a skin flap and surgical margins greater than 1 mm - You are scheduled to receive post-operative radiation therapy (IMRT or proton therapy) - You may also receive concurrent chemotherapy **You may NOT be eligible if...** - You had a small local flap reconstruction that limits radiation planning flexibility - You have had previous radiation treatment to the head and neck area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStandard post-operative radiotherapy without flap sparing (current practice)

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

RADIATIONPost-operative radiotherapy with flap sparing

Post-operative radiotherapy with flap sparing


Locations(25)

Chu Amiens

Amiens, France

Institut de Cancérologie de l'Ouest

Angers, France

Centre François Baclesse

Caen, France

CHU CAEN

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

CHIC

Créteil, France

Centre Georges-François Leclerc

Dijon, France

Centre Guillaume le Conquérant

Le Havre, France

Centre Hospitalier

Libourne, France

Centre Oscar Lambret

Lille, France

Centre Léon Bérard

Lyon, France

APHM Marseille

Marseille, France

Institut Régional du Cancer Val D'aurelle

Montpellier, France

Institut de Cancérologie de Lorraine

Nancy, France

Centre Antoine Lacassagne

Nice, France

APHP La Pitié

Paris, France

Chu Poitiers

Poitiers, France

Institut Jean Godinot

Reims, France

Centre Eugène Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

Chu Rouen

Rouen, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

IUCT

Toulouse, France

Chu Tours

Tours, France

Institut Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT06798922


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