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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Standard post-operative radiotherapy without flap sparing (current practice)
RadiationStandard post-operative radiotherapy without flap sparing (current practice)
Post-operative radiotherapy with flap sparing
RadiationPost-operative radiotherapy with flap sparing
Treatment groups
348 Participants
are divided into 2 treatment groupsGroup A: Standard armActive comparator 1 intervention
Group B: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 radiotherapySecondary outcomes
1
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 radiotherapySponsors and contacts
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Source ClinicalTrials.gov