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

Phase 2

Completed

• Conditions: Craniopharyngioma
• Interventions: Radiation: Protontherapy

• Registration Number: NCT02842723
• Lead Sponsor: Institut Curie

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-25
• Primary Completion: 2018-11-13
• Study Completion: 2021-02-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Protontherapy	Protontherapy	-

Primary Outcome Measures

Name	Time	Method
local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy	at 3 years

Secondary Outcome Measures

Name	Time	Method
visual pathway tolerance according to NCI-CTC v3.0 scale	through study completion, up to 9 years

Trial Locations

Locations (3)

Gustave Roussy; 🇫🇷 Villejuif, France

Groupe Hospitalier Necker Enfants Malades; 🇫🇷 Paris, France

Institut Curie; 🇫🇷 Paris, France