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

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

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).

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]).

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