This trial is active, not recruiting.

Condition craniopharyngioma
Treatment protontherapy
Phase phase 2
Sponsor Institut Curie
Start date March 2010
End date December 2018
Trial size 33 participants
Trial identifier NCT02842723, IC 2008-01


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
59,5 Gy (1,7 Gy daily, 5 fractions per week).

Primary Outcomes

local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy
time frame: at 3 years

Secondary Outcomes

visual pathway tolerance according to NCI-CTC v3.0 scale
time frame: through study completion, up to 9 years

Eligibility Criteria

Male or female participants from 3 years up to 16 years old.

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

Additional Information

Official title Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Institut Curie.