Comparing two methods for reconstructing the jaw in oral cancer patients
A Randomized Prospective Multicenter Study Comparing Fibula Free-flap Mandibular Reconstruction With or Without Preoperative Virtual Planning in Patients With Oral or Oropharyngeal Cancer
This study is testing if using advanced planning tools before jaw surgery helps oral cancer patients recover better than traditional surgery methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unicancer Academic / other |
| Locations | 10 sites (Bordeaux and 9 other locations) |
| Trial ID | NCT04725396 on ClinicalTrials.gov |
What this trial studies
This national multicenter study aims to compare the effectiveness of mandibular reconstruction (MR) with and without preoperative virtual planning (PVP) in patients diagnosed with oral or oropharyngeal cancer. The study involves randomizing patients into two groups, where one group will receive MR with PVP, which includes the use of surgical cutting guides and preformed plates for flap osteosynthesis, while the other group will undergo conventional MR without PVP. The goal is to determine if the use of PVP improves surgical outcomes in these patients. All procedures will be performed by a multidisciplinary team following a standardized protocol.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with primary or recurrent histologically proven oral or oropharyngeal cancer requiring segmental mandibulectomy and immediate fibula free flap reconstruction.
Not a fit: Patients who do not require segmental mandibulectomy or those with poor performance status or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and recovery for patients undergoing jaw reconstruction after cancer surgery.
How similar studies have performed: Previous studies have shown promising results with the use of preoperative virtual planning in surgical procedures, suggesting potential benefits in this context as well.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 9 other locations
- CHU Groupe Hospitalier Pellegrin — Bordeaux, France (Recruiting)
- Centre François Baclesse — Caen, France (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- CHU Gui de Chauliac — Montpellier, France (Recruiting)
- CHU Hotel Dieu — Nantes, France (Recruiting)
- Centre Antoine Lacassagne — Nice, France (Recruiting)
- CHU Pontchaillou — Rennes, France (Recruiting)
- Iuct-O — Toulouse, France (Recruiting)
- CHR de Valenciennes — Valenciennes, France (Recruiting)
- Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Principal investigator: Alexandre BOZEC — Centre Antoine Lacassagne Nice
- Study coordinator: Michaël CHEVROT, Ph.D
- Email: m-chevrot@unicancer.fr
- Phone: +33171936161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.