Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy (Craniopharyngioma)
This trial is active, not recruiting.
|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|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy
time frame: at 3 years
visual pathway tolerance according to NCI-CTC v3.0 scale
time frame: through study completion, up to 9 years
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
|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).|
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