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NCT Number: NCT01272622

Prospective Study of Children and Adolescents With Craniopharyngioma

The present investigation is a prospective, multicenter study evaluating craniopharyngioma patients' prognoses following the various currently-practiced therapeutic strategies.Primary goals of the study are to establish quality standards and compare the various therapy strategies with respect to their effectiveness and impact on the quality of life of treated patients. A stratified randomization of two treatment arms will be conducted with respect to timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose tumors are incompletely resected. The researchers will investigate whether an immediate, postoperative irradiation is superior to progression-contingent irradiation based on alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month post op) to 3 years after randomization. Progression-free survival and overall survival will be examined as closely-related subgoals.Postoperative data will be evaluated via a surveillance study for all complete resection patients as well as for those patients under 5 years of age regardless of their resection grade.

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Key information

Conditions

Craniopharyngioma Body Weight Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Oldenburg

Oldenburg, Lower Saxony, 26133, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with craniopharyngioma for the first time
  • Age at diagnosis 18 years or less of age
  • Agreement from patient's parents or legal guardian as well as the patient

Criteria for inclusion in randomization study

  • Histological diagnosis of craniopharyngioma
  • Age at diagnosis 18 years or less of age
  • Age at primary surgery over 5 years of age
  • Incomplete primary resection
  • Reference radiological confirmation of an incomplete resection
  • Agreement from patient's parents or legal guardian as well as the patient

Exclusion criteria

Age at diagnosis over 18 years of age No QoL measurement for randomization (3 months after surgery).

Treatment and study plan

Radiation

Radiation

Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy)

wait and watch

Other

wait ans watch, MRI controls, irradiation at the time of progression of residual tumor

Primary outcomes

  1. Quality of life

    Time frame: 3 years after diagnosis

    •Randomized investigation of children (≥ 5 years of age) and adolescent QoL changes (main goal assessment) following incomplete craniopharyngioma resections at primary diagnosis per QoL endpoint scores (PEDQOL "physical functions" domain) measured from 3rd month after surgery for 3 years after randomization; and the progression-free and total survival rates (subgoal assessments) relative to how these rates relate to postoperative irradiation timing (immediate postsurgery irradiation versus wait-and-see approach + progression-contingent irradiation of residual tumor).

Secondary outcomes

  1. Rate of Progression or relapse

    Time frame: 3 years after surgery

    • Compilation of applied therapy strategies for craniopharyngiomas in children and adolescents using data capture conforming to SIOP brain tumor groups
    • Evaluation of patients' remission status following the various therapy strategies/modalities for craniopharyngiomas using data detection consistent with SIOP brain tumor groups
    • Evaluation of the health status (ophthalmologic, neuropsychologic and endocrine conditions) and health-related QoL of children and adolescents following treatment of craniopharyngiomas using data capture conforming to SIOP brain tumor groups

Sponsors and collaborators

Lead sponsor

Klinikum Oldenburg gGmbH

Other

Collaborators

  • Arbeitsgemeinschaft Pädiatrische Endokrinologie (APE)
  • Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)
  • Deutsche Gesellschafr für Radioonkologie (DEGRO)
  • Deutsche Gesellschaft für Endokrinologie (DGE)
  • Deutsche Kinderkrebsstiftung
  • German Society for Pediatric Oncology and Hematology GPOH gGmbH
  • International Society of Paediatric Oncology

Registry information

Official study title

KRANIOPHARYNGEOM 2007 - Multicenter Prospective Study of Children and Adolescents With Craniopharyngioma

Important dates

Study start
2007
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2011
Registry last updated
Nov 6, 2019

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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