Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy (Craniopharyngioma)

Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy

Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.

This study is phase II prospective, open labelled, phase ii, monocenter. The main objective is to evaluate the fractionated high precision radiotherapy with a dose of 59,5 Gy (1,7 Gy daily, 5 fractions per week).

Inclusion Criteria:

• Histologically documented craniopharyngioma
• Age range between 3 and 16 years
• Landsky performance status > 60
• Incomplete surgical resection or simple biopsy
• Solid and/or cystic aspect on imaging
• Irradiation performed at the time of presentation or of local progression
• Signed informed consent by parents or by legal representative (with copy to each participating center)

Exclusion Criteria:

• Previous history of radiotherapy (including stereotactic) administered to the head and neck region
• Severe vasculopathy
• Participation to a concurrent study
• Contra-indication to general anesthesia in children below 5 years
• Patient non-compliant to a minimum 30 mn immobilisation
• Patient deprived of freedom or under guardianship
• Patient not expected to be followed in a long run