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

Craniopharyngioma Clinical Trial

Official title:

Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842723
• Other study ID #: IC 2008-01
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: February 2, 2021

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2, 2021
• Est. primary completion date: November 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Craniopharyngioma

Intervention

Radiation:
• Protontherapy
59,5 Gy (1,7 Gy daily, 5 fractions per week).

Locations

Country	Name	City	State
France	Groupe Hospitalier Necker Enfants Malades	Paris
France	Institut Curie	Paris
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy		at 3 years
Secondary	visual pathway tolerance according to NCI-CTC v3.0 scale		through study completion, up to 9 years