Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC (NCT04725396) | Clinical Trial Compass
CompletedNot Applicable
Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC
France132 participantsStarted 2021-04-20
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. 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
✕. Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion