At a glance
ClinicalIndex Comparison Record- ✓Oral cavity cancer or oropharyngeal cancer with flap extending into oral cavity, treated with reconstructive flap surgery
- ✓Resection margins greater than 1 mm
- ✓Candidate for post-operative IMRT or proton therapy
- ✓Age 18 years or older
- ✕Local flap with small size limiting IMRT modulation potential
- ✕Prior head and neck radiotherapy
- ✕Metastatic disease
- ✕Other malignancy within previous 3 years (except in-situ cervix carcinoma or non-melanoma skin carcinoma)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers: a De-escalation Randomized Phase III Trial
In Brief
A Phase 3 clinical trial evaluating Standard post-operative radiotherapy without flap sparing (current practice) and Post-operative radiotherapy with flap sparing for Oral Cavity Carcinoma and 3 related conditions. Currently recruiting, targeting 348 participants across 25 sites.
Detailed 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)
Study Details
Timeline
Interventions
Standard post-operative radiotherapy without flap sparing (current practice)
Post-operative radiotherapy with flap sparing