Spots Global Cancer Trial Database for Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC

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Trial Identification

Brief Title: Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC

Official Title: A Randomized Prospective Multicenter Study Comparing Fibula Free-flap Mandibular Reconstruction With or Without Preoperative Virtual Planning in Patients With Oral or Oropharyngeal Cancer

Study ID: NCT04725396

Conditions

Oropharynx Squamous Cell Carcinoma

Oral Cavity Squamous Cell Carcinoma

Interventions

Mandibular Reconstruction (MR) with Preoperative Virtual Planning (PVP).

Conventional Mandibular Reconstruction (MR without PVP)

Study Description

Brief 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).

Detailed 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 \[0-1 vs 2-3\]).