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

Institut Curie

Status and phase

Completed

Phase 2

Conditions

Craniopharyngioma

Treatments

Radiation: Protontherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02842723

IC 2008-01

Details and patient eligibility

About

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

Full 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).

Enrollment

33 patients

Sex

All

Ages

3 to 16 years old

Volunteers

No Healthy Volunteers

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