Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

NCT06798922

RecruitingPhase 3

Sponsor: Centre Francois Baclesse

Conditions: Oral Cavity Carcinoma, Flap, Radiotherapy, Adjuvant, Reconstruction Surgery

Interventions: Standard post-operative radiotherapy without flap sparing (current practice), Post-operative radiotherapy with flap sparing

Countries: France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (30)
  • Amiens, France
  • Angers, France
  • Avranches, France
  • Caen, France
  • Caen, France
  • Cherbourg, France
  • Clermont-Ferrand, France
  • Créteil, France
  • Dijon, France
  • Le Havre, France
  • Libourne, France
  • Lille, France
  • Limoges, France
  • Lyon, France
  • Marseille, France
  • Montpellier, France
  • Nancy, France
  • Nice, France
  • Paris, France
  • Poitiers, France
  • Reims, France
  • Reims, France
  • Rennes, France
  • Rouen, France
  • Rouen, France
  • Rouen, France
  • Saint-Herblain, France
  • Toulouse, France
  • Tours, France
  • Villejuif, France