Evaluation of the Benefit of a New Surgical Procedure According to IDEAL Recommendations for ORL Cancer Patients: the External Pudendal Flap Used as a New Free Flap for Oral Cavity/Oropharyngeal Reconstruction to Limit Donor Site Sequelae

Recruiting N/A Interventional Study
Head and Neck Cancer Oral Cavity Cancer Oropharynx Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
40 (estimated)
Sponsor
Institut Claudius Regaud · Other
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About This Trial
This is a phase 1b, multicenter, non-randomized prospective study involving an innovation phase (IDEAL-1) followed by a prospective development phase (IDEAL-2A) designed to evaluate the safety and feasibility of oral/oropharyngeal reconstruction with the external pudendal free flap in two groups of patients. A maximum of 40 patients (20 patients per group) will be included in this IDEAL-1/2A phas…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patient with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx. 2. Patient whose disease is classified UICC TNM stade (8th edition) : T0-4a N0/N2c M0 (no distant metastasis M0). 3. Patient whose oral cavity or …
Contacts

Agnès DUPRET-BORIES

05 31 15 53 08

dupret-bories.agnes@iuct-oncopole.fr

CONTACT