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

NCT04725396 | Completed DMC

• 2 other identifiers: UC-HNG-20092020-A02655-34
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 10

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).

Conditions

Oropharynx Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma

Keywords

fibula free-flap; mandibular reconstruction; preoperative virtual planning

Outcome Measures

Primary Outcomes (1)

• General Oral Health Assessment Index (GOHAI)

  Oral health-related quality of life (QoL) measured 1 year after surgery using the GOHAI in the 2 groups of patients (MR with or without PVP). The GOHAI is an oral-disease-specific QoL measure made by the patient. The GOHAI comprises 12 items grouped into three dimensions: the functional dimension (eating, speaking, swallowing); the pain or discomfort dimension (drugs, gingival sensitivity, discomfort when chewing certain foods); and, the psychosocial dimension (concerns, relational discomfort, appearance). The response format for each item is based on a five-point Likert scale: always = 1; often = 2; sometimes = 3; seldom = 4; never = 5. A summary score (ranging from 0 to 60) is calculated for each patient with a higher score indicating better oral health. GOHAI scores close to 30 have been reported in head and neck cancer patients after oncologic surgery and pedicled or free flap reconstruction.

  1-year

Secondary Outcomes (17)

• Time between randomization and surgery

  At the time of surgery, up to 45 days after randomization

• Total operative time and flap ischemia time

  Post surgery, up to 45 days after randomization

• Postoperative surgical complication rate (including free-flap failure rate)

  Post surgery, up to 45 days after randomization

• Delayed surgical complication rate

  Post surgery, up to 45 days after randomization

• Functional outcome: Performance Status Scales for Head and Neck (PSS-HN)

  At baseline and at 1 year

Study Arms (2)

Patients undergoing PVP-assisted MR

EXPERIMENTAL

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).

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

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

ACTIVE COMPARATOR

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.

Device: Conventional Mandibular Reconstruction (MR without PVP)

Interventions

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

Conventional Mandibular Reconstruction (MR without PVP) DEVICE

Conventional Mandibular Reconstruction

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or over
• Primary or recurrent OOPC, histologically proven, requiring segmental mandibulectomy
• Planned immediate fibula free flap MR to be performed at the same time as the tumor ablation by segmental mandibulectomy
• MR requiring at least one osteotomy for contouring the flap (i.e. at least 2 bone fragments)
• East Cooperative Oncology Group (ECOG) performance status 0 or 1
• American Society of Anesthesiologists Physical Status (ASA) score 1, 2, or 3
• Patients considered fit for surgery as decided by the multidisciplinary team
• 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
• Patients must be affiliated to a Social Security System (or equivalent)
• 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

You may not qualify if:

• Non resectable tumors (T4b primary tumor, non resectable metastatic lymph nodes)
• Comorbidities factors that would contraindicate surgery (such as severe peripheral artery disease)
• MR requiring no osteotomy for contouring the flap (i.e. one bone fragment)
• 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
• Other uncontrolled malignancy
• Serious, non-healing or dehiscing wound, active ulcer or ongoing bone fracture at the free-flap donor site
• Patients unwilling or unable to comply with the medical follow-up required by the trial because of psychosocial, familial, social, or geographical reasons
• Patients deprived of their liberty or under protective custody or guardianship

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (10)

CHU Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, France

Location

Centre Oscar Lambret

Lille, France

Location

CHU Gui de Chauliac

Montpellier, France

Location

CHU Hotel Dieu

Nantes, France

Location

Centre Antoine Lacassagne

Nice, 06 103, France

Location

CHU Pontchaillou

Rennes, France

Location

IUCT-O

Toulouse, France

Location

CHR de Valenciennes

Valenciennes, France

Location

Gustave Roussy

Villejuif, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Mandibular Reconstruction

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Orthognathic Surgical Procedures; Oral Surgical Procedures; Dentistry

Study Officials

• Alexandre BOZEC

  Centre Antoine Lacassagne, Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: April 20, 2021
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)