Prospective Study of Children and Adolescents With Craniopharyngioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Klinikum Oldenburg gGmbH.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention
Craniopharyngioma
Obesity
Radiation: Radiation
Other: wait and watch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: KRANIOPHARYNGEOM 2007 - Multicenter Prospective Study of Children and Adolescents With Craniopharyngioma

Resource links provided by NLM:


Further study details as provided by Klinikum Oldenburg gGmbH:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: October 2007
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Radiation: Radiation
Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy)
Arm II
incomplete resection and irradiation at the time of progression of residual tumor
Other: wait and watch
wait ans watch, MRI controls, irradiation at the time of progression of residual tumor

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272622

Contacts
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

Locations
Germany
Klinikum Oldenburg Recruiting
Oldenburg, Niedersachsen, Germany, 26133
Contact: Hermann L Mueller, MD    +49 441 403 ext 2013    mueller.hermann@klinikum-oldenburg.de   
Contact: Ursel Gebhardt, phD    +49 441 403 ext 2072    kikra.doku@klinikum-oldenburg.de   
Principal Investigator: Hermann L Mueller, MD         
Sponsors and Collaborators
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)
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. Hermann Mueller, Klinikum Oldenburg gGmbH
ClinicalTrials.gov Identifier: NCT01272622     History of Changes
Other Study ID Numbers: DKSR 463
Study First Received: January 7, 2011
Last Updated: August 8, 2011
Health Authority: Germany: Ethical board
Germany: Federal Office for Radiation Protection

Keywords provided by Klinikum Oldenburg gGmbH:
Quality of life
Endocrinology
Oncology
Hypothalamus
Irradiation
Neurosurgery
Pediatric Brain tumors
Randomized trial

Additional relevant MeSH terms:
Craniopharyngioma
Adamantinoma
Obesity
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 21, 2014