Biomedical Innovation for Facial Bone Reconstruction in Oncology: BIOFACE PASS a Medico-economic Study Describing the Standard Pathway of Patients Treated by Free Bone Flap

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Jan 10, 2025

Keywords

ClinConnect Summary

The BIOFACE PASS trial is a study aimed at understanding how patients with head and neck cancers are treated when they need surgery to reconstruct facial bones. Specifically, it focuses on patients who have oral cavity or upper throat cancers and require a special type of surgery called mandibulectomy or segmental maxillectomy, which involves removing parts of the jaw or upper jaw. The study will look at the standard care process for these patients, particularly those who will receive a "free bone flap" for reconstruction, which is a method where a piece of bone is taken from another part of the body to rebuild the facial structure.

To be eligible for this trial, patients must be at least 18 years old and diagnosed with advanced stage head and neck cancer that can be treated with surgery. They must also be part of the French Social Security system and give their consent to participate. However, certain factors may exclude someone from participating, such as having previous radiation treatment or specific health issues that could complicate the surgery. While the study is not yet recruiting participants, it aims to provide valuable insights into the treatment pathway for those facing significant facial reconstruction after cancer surgery.

Gender

ALL

Eligibility 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)