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)
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) Our purpose is to demonstrate the feasibility of sparing surgical flaps from radiotherapy, in order to reduce toxicity while maintaining local disease control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
348
Standard post-operative radiotherapy without flap sparing (current practice)
Post-operative radiotherapy with flap sparing
loco-regional control rate
To evaluate whether flap sparing yields non-inferior 2-year loco-regional control rate as flap-agnostic radiotherapy (as per standard routine practice) in completely resected oral cavity carcinomas undergoing postoperative radiotherapy
Time frame: 2 years after the end of postoperative radiotherapy
Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities
Rate of Ear-Nose-Throat (ENT) toxicities among cavity cancer patients with a flap, defined as the proportion of oral cavity cancer patients with at least two ENT toxicities grade ≥ 2 according to NCI-CTCAE v5.0
Time frame: within 12 months after postoperative radiotherapy
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Chu Amiens
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