Status:
COMPLETED
Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC
Lead Sponsor:
UNICANCER
Conditions:
Oropharynx Squamous Cell Carcinoma
Oral Cavity Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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/or...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion
- Patients deprived of their liberty or under protective custody or guardianship
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2025
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04725396
Start Date
April 20 2021
End Date
October 15 2025
Last Update
November 20 2025
Active Locations (10)
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1
CHU Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
2
Centre François Baclesse
Caen, France
3
Centre Oscar Lambret
Lille, France
4
CHU Gui de Chauliac
Montpellier, France