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Completed

NCT Number: NCT02842723

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

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

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Key information

Conditions

Craniopharyngioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Groupe Hospitalier Necker Enfants Malades, Paris, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

protontherapy

Radiation

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

Primary outcomes

  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 outcomes

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

    Time frame: through study completion, up to 9 years

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2018
Study completion
2021
First posted
Jul 25, 2016
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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