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

NCT02842723 | Completed Phase 2

• 1 other identifier: IC 2008-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Craniopharyngioma

Keywords

craniopharyngioma; protontherapy

Outcome Measures

Primary Outcomes (1)

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

  at 3 years

Secondary Outcomes (1)

• visual pathway tolerance according to NCI-CTC v3.0 scale

  through study completion, up to 9 years

Study Arms (1)

Protontherapy

EXPERIMENTAL

Radiation: Protontherapy

Interventions

Protontherapy RADIATION

59,5 Gy (1,7 Gy daily, 5 fractions per week).

Protontherapy

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (3)

Institut Curie

Paris, 75005, France

Location

Groupe Hospitalier Necker Enfants Malades

Paris, 75015, France

Location

Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Craniopharyngioma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 25, 2016
• Study Start: March 1, 2010
• Primary Completion: November 13, 2018
• Study Completion: February 2, 2021
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA

Locations

FR (3)