Clinical Trial: Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy (Craniopharyngioma)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy
Brief Summary: Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.
Detailed Summary: 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).
Sponsor: Institut Curie
Current Primary Outcome: local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy [ Time Frame: at 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: visual pathway tolerance according to NCI-CTC v3.0 scale [ Time Frame: through study completion, up to 9 years ]
Original Secondary Outcome: Same as current
Information By: Institut Curie
Dates:
Date Received: July 11, 2016
Date Started: March 2010
Date Completion: December 2020
Last Updated: July 20, 2016
Last Verified: July 2016