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

Prior treatment

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

Other illness

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

Other

• Non resectable tumors (T4b primary tumor, non resectable metastatic lymph nodes)
• MR requiring no osteotomy for contouring the flap (i.e. one bone fragment)
• 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

• 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