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Clinical Trial Summary

This is a national multicenter, randomized, stratified, open label study, aiming to compare mandibular reconstruction (MR) with or without preoperative virtual planning (PVP), in patients with oral/oropharyngeal cancer (OOPC).


Clinical Trial Description

PVP-assisted MR includes the production of the surgical cutting guides required for mandibular resection and fibula free-flap conformation and of the preformed plates for flap osteosynthesis (for all patients, PVP will be done by the same laboratory: Materialise laboratory). PVP-assisted MR includes the production of : - surgical cutting guides required for mandibular resection and fibula free-flap conformation - preformed plates for flap osteosynthesis Patients will be selected after the multidisciplinary decision of oncological surgery including segmental mandibulectomy and immediate MR. Patients will be randomized in 2 groups (ratio 1:1, stratified on center and tumor N status [0-1 vs 2-3]). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04725396
Study type Interventional
Source UNICANCER
Contact Michaël CHEVROT, Ph.D
Phone +33171936161
Email m-chevrot@unicancer.fr
Status Recruiting
Phase N/A
Start date April 20, 2021
Completion date December 1, 2024

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