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

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ClinicalTrials.gov Identifier: NCT02842723
Recruitment Status : Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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 : March 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Measures :
  1. visual pathway tolerance according to NCI-CTC v3.0 scale [ Time Frame: through study completion, up to 9 years ]


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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842723


Locations
France
Institut Curie
Paris, France, 75005
Groupe Hospitalier Necker Enfants Malades
Paris, France, 75015
Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Institut Curie

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02842723     History of Changes
Other Study ID Numbers: IC 2008-01
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut Curie:
craniopharyngioma
protontherapy

Additional relevant MeSH terms:
Craniopharyngioma
Adamantinoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases