Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Prospective, Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258453
• Other study ID #: GPOH-CRANIOPHARYNGIOMA-2000
• Secondary ID: CDR0000450768EU-
• Status: Completed
• Phase: N/A
• First received: November 22, 2005
• Last updated: August 1, 2013
• Start date: May 2001
• Est. completion date: September 2009

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Collecting information on how craniopharyngioma is diagnosed and treated may help doctors predict a patient's response to treatment and help plan the best treatment. It may also help identify the intermediate- and long-term effects of treatment.

PURPOSE: This clinical trial is collecting information on diagnosis, treatment, and quality of life of young patients who are undergoing surgery for craniopharyngioma.

Description:

OBJECTIVES:

Primary

• Identify all applied therapy strategies in pediatric patients with craniopharyngioma.

• Correlate relapse status with different therapy strategies/modality in these patients.

• Determine the health status (i.e., ophthalmologic, neuropediatric, and endocrine findings) and the health-related quality of life of these patients after treatment.

Secondary

• Determine the incidence of craniopharyngioma in pediatric patients.

• Identify quality control measures for diagnosis and therapy in these patients.

• Improve long-term care through a standardized follow-up program in these patients.

• Determine the efficacy of endocrine substitution for postoperative hypopituitarism in these patients.

• Identify risk factors for developing obesity and correlate the neurotransmitter concentration of leptin and neuropeptide Y in cerebral spinal fluid, serum, and craniopharyngioma cystic fluid with the likelihood of developing obesity in these patients.

• Determine the incidence and extent of eating disorders in these patients.

OUTLINE: This is a multicenter study.

Patients undergo neurologic, endocrine, and ophthalmologic tests and anthropometric diagnostic measurements. Patients then undergo 1 of the following surgical procedures: total resection; incomplete, subtotal, or partial resection; biopsy; or cyst pressure release. Patients whose tumor relapses may undergo a second resection and/or radiotherapy.

Quality of life is assessed at baseline and then periodically thereafter.

After surgery, patients are followed periodically.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2009
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of primary craniopharyngioma by MRI and CT scan (initial diagnosis)

• Patients with only cystic sellar or parasellar malformation (e.g., Rathke pouch cysts or suprasellar cysts) are allowed but will undergo observation only

PATIENT CHARACTERISTICS:

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

PRIOR CONCURRENT THERAPY: Not specified

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Body Weight Changes
• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Craniopharyngioma
• Long-term Effects Secondary to Cancer Therapy in Children
• Nervous System Neoplasms
• Perioperative/Postoperative Complications
• Postoperative Complications
• Psychosocial Effects of Cancer and Its Treatment
• Weight Changes

Intervention

Other:
• metabolic assessment

• physiologic testing

Procedure:
• biopsy

• computed tomography

• conventional surgery

• magnetic resonance imaging

• management of therapy complications

• psychosocial assessment and care

• quality-of-life assessment

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Austria	Krankenhaus Dornbirn	Dornbirn
Austria	Landeskrankenhaus Feldkirch	Feldkirch-Tisis
Austria	Universitaet Kinderklinik	Graz
Austria	Innsbruck Universitaetsklinik	Innsbruck
Austria	Landeskrankenhaus Klagenfurt	Klagenfurt
Austria	LKH Leoben	Leoben
Austria	A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung	Linz
Austria	Landes-Kinderkrankenhaus	Linz
Austria	St. Johanns-Spital	Salzburg
Austria	Kardinal Schwarzenbersches Krankenhaus Betriebsgesellschraft mbH Kinderspital	Schwarzach
Austria	A. oe. Landeskrankenhaus Abt. fuer Kinderkrankheiten	Steyr
Austria	St. Anna Children's Hospital	Vienna
Austria	Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik	Wien
Germany	Kinderklinik - Universitaetsklinikum Aachen	Aachen
Germany	Klinikum Augsburg	Augsburg
Germany	Caritas-Krankenhaus Bad Mergentheim	Bad Mergentheim
Germany	Klinikum am Bamberg	Bamberg
Germany	Klinikum Bayreuth	Bayreuth
Germany	Charite - Campus Charite Mitte	Berlin
Germany	Charite University Hospital - Campus Virchow Klinikum	Berlin
Germany	Helios Klinikum Berlin	Berlin
Germany	Evangelisches Krankenhauus Bielfeld	Biefeld
Germany	Kinderklinik der Universitaet Bonn	Bonn
Germany	Klinikum Bremen-Mitte	Bremen
Germany	Allgemeinen Krankenhaus Celle Kinderklinik	Celle
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Klinikum Coburg	Coburg
Germany	Children's Hospital	Cologne
Germany	Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl	Cologne
Germany	Carl - Thiem - Klinkum Cottbus	Cottbus
Germany	Vestische Kinderklinik Universitaetsklinik Witten/Herdecke	Datteln
Germany	Klinikum Lippe - Detmold	Detmold
Germany	Staedtisches Krankenhaus Dresden - Neustadt	Dresden
Germany	Universitatsklinikum Carl Gustav Carus	Dresden
Germany	Klinikum Duisburg	Duisburg
Germany	Klinikum Erfurt	Erfurt
Germany	Universitaets - Kinderklinik	Erlangen
Germany	Klinikum der J.W. Goethe Universitaet	Frankfurt
Germany	Universitaetskinderklinik - Universitaetsklinikum Freiburg	Freiburg
Germany	Kinderklinik	Giessen
Germany	Universitaetsklinikum Goettingen	Goettingen
Germany	Universitats - Kinderklinik	Greiswald
Germany	Kreiskrankenhaus Gummersbach GMBH	Gummersbach
Germany	Universitaetsklinikum Halle	Halle
Germany	University Medical Center Hamburg - Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Kreskrankenhaus Kinderabteilung	Heide
Germany	Universitaets-Kinderklinik Heidelberg	Heidelberg
Germany	SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen	Heilbronn
Germany	Gemeinschaftskrankenhaus	Herdecke
Germany	Staedtisches Krankenhaus Hildesheim	Hildesheim
Germany	Universitaetsklinikum des Saarlandes	Homburg
Germany	Clinic for Bone Marrow Transplantation and Hematology and Oncology	Idar-Oberstein
Germany	Universitaets - Kinderklinik	Jena
Germany	Municipal Hospital Complex of the University	Kaiserslautern
Germany	Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe
Germany	Klinikum Kassel	Kassel
Germany	Staedtisches Krankenhaus Kiel	Kiel
Germany	University Hospital Schleswig-Holstein - Kiel Campus	Kiel
Germany	Klinikum Kemperhof Koblenz	Koblenz
Germany	Klinik Konstanz	Konstanz
Germany	Klinikum Krefeld GmbH	Krefeld
Germany	Kinderkrankenhaus St. Marien	Landshut
Germany	Universitaets - Kinderklinik	Leipzig
Germany	St. Annastift Krankenhaus	Ludwigshafen
Germany	Universitaets - Kinderklinik - Luebeck	Luebeck
Germany	Universitatsklinikum der MA	Magdeburg
Germany	Johannes Gutenberg University	Mainz
Germany	Staedtisches Klinik - Kinderklinik	Mannheim
Germany	Universitaets - Kinderklinik	Marburg
Germany	Klinikum Minden	Minden
Germany	Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin	Moenchengladbach
Germany	Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster	Muenster
Germany	Dr. von Haunersches Kinderspital der Universitaet Muenchen	Munich
Germany	Krankenhaus Muenchen Schwabing	Munich
Germany	Staedtisches Krankenhaus Muenchen - Harlaching	Munich
Germany	Klinikum Neubrandenburg	Neubrandenburg
Germany	Lukaskrankenhaus Neuss	Neuss
Germany	Marienhaus Klinikum St. Elisabeth Neuwied	Neuwied
Germany	Cnopf'sche Kinderklinik	Nuremberg
Germany	Klinikum Nuernberg - Klinikum Sued	Nuremberg
Germany	Klinikum Oldenburg	Oldenburg
Germany	Marien Hospital	Osnabruck
Germany	Paracelsus - Klinik Osnabrueck	Osnabrueck
Germany	Klinik St. Hedwig-Kinderklinik	Regensburg
Germany	Kinderklinik - Universitaetsklinikum Rostock	Rostock
Germany	Saarbrucker Winterbergkliniken	Saarbrucken
Germany	Klinikum Schwerin	Schwerin
Germany	Kinderklink Siegen Deutsches Rotes Kreuz	Siegen
Germany	Johanniter-Kinderklinik	St. Augustin
Germany	Olgahospital	Stuttgart
Germany	Krankenanstalt Mutterhaus der Borromaerinnen	Trier
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm	Ulm
Germany	St. Marienhospital - Vechta	Vechta
Germany	Staedtisches Klinikum - Howedestrase	Vechta
Germany	Dr. Horst-Schmidt-Kliniken	Wiesbaden
Germany	Reinhard-Nieter-Krankenhaus	Wilhelmshaven
Germany	Klinikum der Stadt Wolfsburg	Wolfsburg
Germany	Universitaets - Kinderklinik Wuerzburg	Wuerzburg
Germany	Helios Kliniken Wuppertal University Hospital	Wuppertal
Sweden	Lanssjukhuset Ryhov	Jonkoping
Switzerland	Kantonspital Aarau	Aarau
Switzerland	Universitaets-Kinderspital beider Basel	Basel
Switzerland	Ospedale "la Carita", Locarno	Locarno
Switzerland	Kinderspital Luzern	Lucerne 16
Switzerland	Ostschweizer Kinderspital	St. Gallen
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	University Children's Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany

Countries where clinical trial is conducted

Austria,  Germany,  Sweden,  Switzerland, 

References & Publications (2)

Müller HL, Gebhardt U, Schröder S, Pohl F, Kortmann RD, Faldum A, Zwiener I, Warmuth-Metz M, Pietsch T, Calaminus G, Kolb R, Wiegand C, Sörensen N; study committee of KRANIOPHARYNGEOM 2000/2007. Analyses of treatment variables for patients with childhood — View Citation

Roth CL, Gebhardt U, Müller HL. Appetite-regulating hormone changes in patients with craniopharyngioma. Obesity (Silver Spring). 2011 Jan;19(1):36-42. doi: 10.1038/oby.2010.80. Epub 2010 Apr 8. — View Citation