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

Launched by UNICANCER · Jan 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different approaches to reconstructing the jawbone in patients with cancer of the mouth or throat. Specifically, it compares a method that uses preoperative virtual planning (a detailed computer guide for surgery) with one that does not. The goal is to see which approach leads to better outcomes for patients who need surgery to remove part of their jaw due to oral or oropharyngeal cancer.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of oral or oropharyngeal cancer that requires surgery to remove a segment of the jaw. They should be healthy enough for surgery, as determined by a medical team, and willing to follow the study's requirements, which include attending scheduled visits and treatments. Those who take part can expect to receive individualized care and will be closely monitored throughout the trial. It's important to note that this study is currently recruiting participants, and those interested should discuss it with their healthcare provider.

Gender

ALL

Eligibility criteria

• 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