New biomaterials approach to rebuild jaw and upper jaw after cancer surgery
Standard of Care Pathways Evaluation of Patients Treated for Facial Reconstruction After Surgery for Head and Neck Cancer, Using the Conventional Technique (Free Bone Flap): a Medico-economic Study
This study will see how adults who have part of their jaw or maxilla removed for head and neck cancer recover, what their quality of life is, and what medical and non-medical costs they have after reconstruction with a free bone flap.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Amiens and 8 other locations) |
| Trial ID | NCT06771336 on ClinicalTrials.gov |
What this trial studies
This observational study records the care pathway, costs, and quality of life for patients treated with free vascularized bone flaps (fibula or scapula) after mandibulectomy or maxillectomy for head and neck cancer. Patients complete questionnaires at inclusion, 3 months, and 12 months to capture direct medical and non-medical costs, daily allowances, and quality-of-life measures. Hospital production costs are collected using a micro-costing approach to estimate resource use and economic burden from the provider perspective. The data will describe current standard care and inform development and medico-economic modelling for a new biomaterials-based reconstruction device.
Who should consider this trial
Good fit: Adults (≥18) in France with oral cavity, maxillary, or oropharyngeal cancer staged cT4a N0–N3 M0 who are planned for curative surgery including mandibulectomy or segmental maxillectomy with reconstruction by a free bone flap and who can give informed consent are ideal candidates.
Not a fit: Patients who have had prior radiotherapy, severe coagulation disorders, comorbidities or anatomic issues that prevent free bone flap reconstruction, or who are not eligible for curative treatment are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the project could guide development of biomaterial reconstruction options that improve speech, swallowing, appearance, and reduce overall costs compared with current free bone flaps.
How similar studies have performed: Free vascularized fibula or scapula flaps are the current gold standard for mandibular and maxillary reconstruction, and while medico-economic pathway descriptions exist, the proposed biomaterials replacement is novel and not yet proven in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with oral cavity cancer or maxillary and/or oropharynx cancer * Eligible for treatment by surgery requiring a mandibulectomy or segmental maxillectomy and having a free bone flap for facial reconstruction. * Patient whose disease is classified Stage cT4a, N0 to N3, M0 * Treatment with a feasible curative aim (no contraindication to optimal treatment such as surgery or chemotherapy at a curative dose) * Age greater than or equal to 18 years * Patient affiliated to a Social Security scheme in France * Patient having given written informed consent Non-inclusion Criteria: * Patient having any situation considered by the doctor as a reason for non-inclusion such as stenosis of the leg tripod not allowing reconstruction by fibula, one or more comorbidity(s) not allowing reconstruction by free bone flap or making this reconstruction too much risk * Patient having had previous radiotherapy * Patient with severe coagulation disorders * Patients deprived of liberty or under legal protection regime (curatorship and guardianship, safeguard of justice)
Where this trial is running
Amiens and 8 other locations
- University hospital of Amiens- Picardie — Amiens, France (Not_yet_recruiting)
- University hospital of Lille — Lille, France (Not_yet_recruiting)
- Hospices Civils de Lyon — Lyon, France (Not_yet_recruiting)
- University hospital of Montpellier — Montpellier, France (Not_yet_recruiting)
- University hospital of Nantes — Nantes, France (Not_yet_recruiting)
- Centre Antoine Lacassagne — Nice, France (Not_yet_recruiting)
- University hospital of Rouen — Rouen, France (Not_yet_recruiting)
- University hospital of Toulouse — Toulouse, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Agnès DUPRET-BORIES — University Hospital, Toulouse
- Study coordinator: Agnès DUPRET-BORIES
- Email: dupretbories.a@chu-toulouse.fr
- Phone: 531156014
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.