About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial population
Participation in the protocol will be offered to all patients meeting the eligibility criteria during the 3-year inclusion period. It is planned to include 200 operated patients, including 50 treated by maxillectomy and 150 treated by mandibulectomy. Nine French cancer centers and university hospitals will participate in the project: the University Hospitals of Toulouse, Amiens, Rouen, Lille, Montpellier, Nantes, the Gustave Roussy Institute, the Antoine Lacassagne Center (Nice) and the Hospices Civil de Lyon.
Trial design
Case-only
Prospective
Treatments tested in this trial
Questionnaires
Other interventionQuality of life questionnaires, questionnaires for assessing functional results, micro-costing questionnaire, informal support assessment questionnaires
Treatment groups
Trial outcomes
Primary outcomes
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
The primary outcome measure is a composite endpoint consisting of the description of care pathways based on care consumption (scheduled and unscheduled hospitalizations and consultations, medical procedures and medications). The study of pathways will take into account data from the National Health Data System (i.e. healthcare consumption). These data will then be aggregated and structured to form time sequences representing the care pathways (and classes of care pathways) of patients using the optimal matching method. These sequences will include several medical events such as consultations, treatments, hospitalizations for example. This will provide us with a simplified but detailed representation of care trajectories. The individual care sequences thus constructed will allow us to carry out sequence analyzes aimed at creating patient clusters.
Sponsors and contacts
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