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

• Sponsor: Institut Curie (Other)
• Overall Status: Completed
• CT.gov ID: NCT02842723
• Collaborator: (none)
• Enrollment: 33
• Locations: 3
• Arm: 1
• Actual Duration (Months): 131.1
• Patients Per Site: 11
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Craniopharyngioma	Radiation: Protontherapy	Phase 2

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy
• Actual Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Nov 13, 2018
• Actual Study Completion Date: Feb 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Protontherapy	Radiation: Protontherapy; 59,5 Gy (1,7 Gy daily, 5 fractions per week).

Outcome Measures

Primary Outcome Measures

1. local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy [at 3 years]

Secondary Outcome Measures

1. visual pathway tolerance according to NCI-CTC v3.0 scale [through study completion, up to 9 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Curie	Paris		France	75005
2	Groupe Hospitalier Necker Enfants Malades	Paris		France	75015
3	Gustave Roussy	Villejuif		France	94800

Sponsors and Collaborators

• Institut Curie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Curie
• ClinicalTrials.gov Identifier: NCT02842723
• Other Study ID Numbers: IC 2008-01
• First Posted: Jul 25, 2016
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Institut Curie: craniopharyngioma; protontherapy
• Additional relevant MeSH terms: Craniopharyngioma; Adamantinoma

Study Results

No Results Posted as of Apr 22, 2022