New biomaterials approach to rebuild jaw and upper jaw after cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University hospital of Toulouse
  Toulouse, France Recruiting
• 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

Study contacts

• Principal investigator: Agnès DUPRET-BORIES — University Hospital, Toulouse
• Study coordinator: Agnès DUPRET-BORIES
• Email: dupretbories.a@chu-toulouse.fr
• Phone: 531156014

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.