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

NCT ID: NCT02842723

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2021-02-02

Brief Summary

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

Detailed Description

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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).

Conditions

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Craniopharyngioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Protontherapy

Group Type EXPERIMENTAL

Protontherapy

Intervention Type RADIATION

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

Interventions

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Protontherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Curie

Paris, , France

Site Status

Groupe Hospitalier Necker Enfants Malades

Paris, , France

Site Status

Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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IC 2008-01

Identifier Type: -

Identifier Source: org_study_id

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