Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Francois Baclesse
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Standard post-operative radiotherapy without flap sparing (current practice)
- Post-operative radiotherapy with flap sparing
Treatment groups
348 Participants
are divided into 2 treatment groupsLocations
25Chu Amiens Amiens France
Institut de Cancérologie de l'Ouest Angers France
Centre François Baclesse Caen France
CHU CAEN Caen France
Sponsors and collaborators
Centre Francois Baclesse
Lead sponsor
Source ClinicalTrials.gov