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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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