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

NCT ID: NCT04725396

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2025-10-15

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]).

Conditions

Oropharynx Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients undergoing PVP-assisted MR

PVP is based on CT-scan with millimetric thin slice acquisitions of the facial bone and fibulas. The surgeon defines the exact sites of the intended mandibular osteotomies. A single external subcontracted laboratory (Materialise®) produces the various cutting guides for mandibular resection, flap conformation and the preformed plates for flap osteosynthesis. Flap conformation is entirely performed at the donor site before section of the vascular pedicle (flap still vascularized).

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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).

Patients undergoing conventional (i.e. without PVP) MR

Flap modeling and positioning requires one or multiple cuneiform osteotomies. The bone transplant is shaped to restore the contours of the mandibular defect using preoperative imaging studies and the resection specimen. Flap conformation begins at the donor site and is generally completed at the recipient site after fibular pedicle section and before microvascular anastomosis (during ischemia time). The different bone fragments are fixed together and to the native mandible using either titanium miniplates or reconstruction plate and monocortical screws. Regardless of the material used for fixing the fibular flap to the native mandible, the use of a reconstruction plate adapted to the native mandible (or other similar techniques) prior to tumor resection is recommended to guide flap shaping and positioning, and to insure an accurate MR.

Group Type: ACTIVE_COMPARATOR

Conventional Mandibular Reconstruction (MR without PVP)

Intervention Type: DEVICE

Conventional Mandibular Reconstruction

Interventions

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).

Intervention Type: DEVICE

Conventional Mandibular Reconstruction (MR without PVP)

Conventional Mandibular Reconstruction

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years or over

2. Primary or recurrent OOPC, histologically proven, requiring segmental mandibulectomy

3. Planned immediate fibula free flap MR to be performed at the same time as the tumor ablation by segmental mandibulectomy

4. MR requiring at least one osteotomy for contouring the flap (i.e. at least 2 bone fragments)

5. East Cooperative Oncology Group (ECOG) performance status 0 or 1

6. American Society of Anesthesiologists Physical Status (ASA) score 1, 2, or 3

7. Patients considered fit for surgery as decided by the multidisciplinary team

8. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures

9. Patients must be affiliated to a Social Security System (or equivalent)

10. Patients must have signed a written informed consent form prior to any trial specific procedures. If the patients are physically unable to give their written consent, a trusted person of their choice, not related to the investigator or the sponsor, can confirm in writing the patient's consent

Exclusion Criteria

1. Non resectable tumors (T4b primary tumor, non resectable metastatic lymph nodes)

2. Comorbidities factors that would contraindicate surgery (such as severe peripheral artery disease)

3. MR requiring no osteotomy for contouring the flap (i.e. one bone fragment)

4. Patients with distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or positron emission tomography (PET)-CT

5. Other uncontrolled malignancy

6. Serious, non-healing or dehiscing wound, active ulcer or ongoing bone fracture at the free-flap donor site

7. Patients unwilling or unable to comply with the medical follow-up required by the trial because of psychosocial, familial, social, or geographical reasons

8. Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion

9. Patients deprived of their liberty or under protective custody or guardianship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre BOZEC

Role: PRINCIPAL_INVESTIGATOR

Centre Antoine Lacassagne, Nice

Locations

CHU Groupe Hospitalier Pellegrin

Bordeaux, , France

Centre François Baclesse

Caen, , France

Centre Oscar Lambret

Lille, , France

CHU Gui de Chauliac

Montpellier, , France

CHU Hotel Dieu

Nantes, , France

Centre Antoine Lacassagne

Nice, , France

CHU Pontchaillou

Rennes, , France

IUCT-O

Toulouse, , France

CHR de Valenciennes

Valenciennes, , France

Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

2020-A02655-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

UC-HNG-2009

Identifier Type: -

Identifier Source: org_study_id