Biomedical Innovation for Facial Bone Reconstruction in Oncology: BIOFACE PASS a Medico-economic … (NCT06771336) | Clinical Trial Compass
RecruitingNot Applicable
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
France200 participantsStarted 2025-09-03
Plain-language summary
The purpose of this study is to describe the standard of care pathway of patients treated by free bone flap for facial mandibullar or maxillar reconstruction after surgery for head and neck cancers.
Who can participate
Age range18 Years
SexALL
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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)
What they're measuring
1
Description of the standard of care pathway of patients treated by free bone flap for facial mandibullar or maxillar reconstruction after surgery for head and neck cancers