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

Primary Purpose

Craniopharyngioma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Protontherapy
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Craniopharyngioma focused on measuring craniopharyngioma, protontherapy

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Curie
  • Groupe Hospitalier Necker Enfants Malades
  • Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Protontherapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2016
Last Updated
April 21, 2022
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT02842723
Brief Title
Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy (Craniopharyngioma)
Official Title
Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 2010 (Actual)
Primary Completion Date
November 13, 2018 (Actual)
Study Completion Date
February 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniopharyngioma
Keywords
craniopharyngioma, protontherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protontherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Protontherapy
Intervention Description
59,5 Gy (1,7 Gy daily, 5 fractions per week).
Primary Outcome Measure Information:
Title
local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy
Time Frame
at 3 years
Secondary Outcome Measure Information:
Title
visual pathway tolerance according to NCI-CTC v3.0 scale
Time Frame
through study completion, up to 9 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Groupe Hospitalier Necker Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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