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

January 29, 2024 updated by: Institut Curie

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Groupe Hospitalier Necker Enfants Malades
      • Paris, France, 75005
        • Institut Curie
      • Villejuif, France, 94800
        • Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy
Time Frame: at 3 years
at 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
visual pathway tolerance according to NCI-CTC v3.0 scale
Time Frame: through study completion, up to 9 years
through study completion, up to 9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2010

Primary Completion (Actual)

November 13, 2018

Study Completion (Actual)

February 2, 2021

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimated)

July 25, 2016

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2008-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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