Clinical trial · Interventional
Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy (Craniopharyngioma)
Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy
NCT02842723CI-TRIAL-00073484completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Craniopharyngioma | Craniopharyngioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Protontherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Protontherapy
- interventionNames
- Radiation: Protontherapy
Primary outcomes (1)
- measure
- local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy
- timeFrame
- at 3 years
Secondary outcomes (1)
- measure
- visual pathway tolerance according to NCI-CTC v3.0 scale
- timeFrame
- through study completion, up to 9 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.