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Prospective Study of Children and Adolescents With Craniopharyngioma

This study is currently recruiting participants.
Verified July 2011 by Klinikum Oldenburg gGmbH
Sponsor:
Collaborators:
German society of pediatric oncology and hematology (GPOH)
Association of pediatric endocrinology (APE)
German Society for Endocrinology (DGE)
Working group pediatric radiation oncology (APRO)
Task force of the German society of radiation oncology (DEGRO)
Deutsche Kinderkrebsstiftung (DKKS)
Information provided by:
Klinikum Oldenburg gGmbH
ClinicalTrials.gov Identifier:
NCT01272622
First received: January 7, 2011
Last updated: August 8, 2011
Last verified: July 2011
History of Changes

January 7, 2011
August 8, 2011
October 2007
April 2013   (final data collection date for primary outcome measure)
Quality of life [ Time Frame: 3 years after diagnosis ] [ Designated as safety issue: Yes ]
•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).
Same as current
Complete list of historical versions of study NCT01272622 on ClinicalTrials.gov Archive Site
Rate of Progression or relapse [ Time Frame: 3 years after surgery ] [ Designated as safety issue: No ]
  • 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
Same as current
Not Provided
Not Provided
 
Prospective Study of Children and Adolescents With Craniopharyngioma
KRANIOPHARYNGEOM 2007 - Multicenter 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Craniopharyngioma
  • Obesity
  • Radiation: Radiation
    Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy)
  • Other: wait and watch
    wait ans watch, MRI controls, irradiation at the time of progression of residual tumor
  • Arm I

    Children and adolescents >= 18 years of age new diagnosed with craniopharyngioma

    • >= 5 years of age and with incomplete resected tumor => randomized in two arms: immediate irradiation after surgery
    Intervention: Radiation: Radiation
  • Arm II
    incomplete resection and irradiation at the time of progression of residual tumor
    Intervention: Other: wait and watch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
April 2014
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Criteria for inclusion in randomization study

  1. Histological diagnosis of craniopharyngioma
  2. Age at diagnosis 18 years or less of age
  3. Age at primary surgery over 5 years of age
  4. Incomplete primary resection
  5. Reference radiological confirmation of an incomplete resection
  6. 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).
Both
up to 18 Years
No
Contact: Hermann L Mueller, MD +49 441 403 ext 2013 mueller.hermann@klinikum-oldenburg.de
Contact: Ursel Gebhardt, phD +49 403 441 ext 2072 kikra.doku@klinikum-oldenburg.de
Germany
 
NCT01272622
DKSR 463
Yes
Prof. Dr. Hermann Mueller, Klinikum Oldenburg gGmbH
Klinikum Oldenburg gGmbH
  • German society of pediatric oncology and hematology (GPOH)
  • Association of pediatric endocrinology (APE)
  • German Society for Endocrinology (DGE)
  • Working group pediatric radiation oncology (APRO)
  • Task force of the German society of radiation oncology (DEGRO)
  • Deutsche Kinderkrebsstiftung (DKKS)
Not Provided
Klinikum Oldenburg gGmbH
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP