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Prospective Study of Children and Adolescents With Craniopharyngioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Klinikum Oldenburg gGmbH
Sponsor:
Collaborators:
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Arbeitsgemeinschaft Pädiatrische Endokrinologie (APE)
Deutsche Gesellschaft für Endokrinologie (DGE)
Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)
Deutsche Gesellschafr für Radioonkologie (DEGRO)
Deutsche Kinderkrebsstiftung
International Society of Paediatric Oncology (SIOP)
Information provided by (Responsible Party):
Prof. Dr. med. Hermann Mueller, Klinikum Oldenburg gGmbH
ClinicalTrials.gov Identifier:
NCT01272622
First received: January 7, 2011
Last updated: September 15, 2016
Last verified: September 2016
  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: September 2017
Estimated Primary Completion Date: December 2016 (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, wait and watch, MRI-controls every 3 months, 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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Arbeitsgemeinschaft Pädiatrische Endokrinologie (APE)
Deutsche Gesellschaft für Endokrinologie (DGE)
Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)
Deutsche Gesellschafr für Radioonkologie (DEGRO)
Deutsche Kinderkrebsstiftung
International Society of Paediatric Oncology (SIOP)
Investigators
Principal Investigator: Hermann L Müller, MD Klinikum Oldenburg gGmbH
  More Information

Responsible Party: Prof. Dr. med. Hermann Mueller, Professor MD, Klinikum Oldenburg gGmbH
ClinicalTrials.gov Identifier: NCT01272622     History of Changes
Other Study ID Numbers: DKSR 463 
Study First Received: January 7, 2011
Last Updated: September 15, 2016
Health Authority: Germany: Ethics Commission
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
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 29, 2016