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 groupsSponsors and collaborators
Source ClinicalTrials.gov