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

NCT04725396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-11-20

No results posted yet for this study

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).

Conditions

  • Oropharynx Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma

Interventions

DEVICE

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

PVP-assisted mandibular reconstruction 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).

DEVICE

Conventional Mandibular Reconstruction (MR without PVP)

Conventional Mandibular Reconstruction

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Alexandre BOZEC · Centre Antoine Lacassagne, Nice

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2025-10-15
Completion
2025-10-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04725396 on ClinicalTrials.gov