Craniopharyngioma
Conditions
Keywords
craniopharyngioma, protontherapy
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).
Interventions
RADIATIONProtontherapy
59,5 Gy (1,7 Gy daily, 5 fractions per week).
Sponsors
Institut Curie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy | at 3 years |
Secondary
| Measure | Time frame |
|---|---|
| visual pathway tolerance according to NCI-CTC v3.0 scale | through study completion, up to 9 years |
Countries
France
Outcome results
None listed