NCT06798922RecruitingPhase 3
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers: a De-escalation Randomized Phase III Trial
Centre Francois Baclesse47 sites in 1 country348 target enrollmentStarted: March 1, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 348
- Locations
- 47
- Primary Endpoint
- loco-regional control rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Standard arm
Active Comparator
Standard IMRT or proton therapy practice, usual CTV definition
Intervention: Standard post-operative radiotherapy without flap sparing (current practice) (Radiation)
Experimental arm
Experimental
IMRT or proton therapy with flap sparing
Intervention: Post-operative radiotherapy with flap sparing (Radiation)
Outcomes
Primary Outcomes
loco-regional control rate
Time Frame: 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 Outcomes
- Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities(within 12 months after postoperative radiotherapy)
Investigators
Study Sites (47)
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