Flap, Oral Cavity Carcinoma, Radiotherapy, Adjuvant, Reconstruction Surgery
Conditions
Keywords
protontherapy, flap, oral cavity carnicoma, radiotherapy, IMRT
Brief 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)
Detailed description
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.
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
Sponsors
Centre Francois Baclesse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| loco-regional control rate | 2 years after the end of postoperative radiotherapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities | within 12 months after postoperative radiotherapy | 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 |
Countries
France
Contacts
CONTACTJuliette THARIAT, Professor
Outcome results
None listed