Clinical trial NCT00258453: Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma
Official title: Prospective, Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain and Central Nervous System Tumors
Long-term Effects Secondary to Cancer Therapy in Children
Perioperative/Postoperative Complications
Psychosocial Effects of Cancer and Its Treatment
Weight Changes
Keywords: psychosocial effects of cancer and its treatment
long-term effects secondary to cancer therapy in children
perioperative/postoperative complications
weight changes
childhood craniopharyngioma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-11-24
Enrollment: 120
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dornbirn
country: Austria
facility: Krankenhaus Dornbirn
city: Feldkirch-Tisis
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Graz
country: Austria
facility: Universitaet Kinderklinik
city: Innsbruck
country: Austria
facility: Innsbruck Universitaetsklinik
city: Klagenfurt
country: Austria
facility: Landeskrankenhaus Klagenfurt
city: Leoben
country: Austria
facility: LKH Leoben
city: Linz
country: Austria
facility: A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung
city: Linz
country: Austria
facility: Landes-Kinderkrankenhaus
city: Salzburg
country: Austria
facility: St. Johanns-Spital
city: Schwarzach
country: Austria
facility: Kardinal Schwarzenbersches Krankenhaus Betriebsgesellschraft mbH Kinderspital
city: Steyr
country: Austria
facility: A. oe. Landeskrankenhaus Abt. fuer Kinderkrankheiten
city: Vienna
country: Austria
facility: St. Anna Children's Hospital
city: Wien
country: Austria
facility: Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
city: Aachen
country: Germany
facility: Kinderklinik - Universitaetsklinikum Aachen
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Mergentheim
country: Germany
facility: Caritas-Krankenhaus Bad Mergentheim
city: Bamberg
country: Germany
facility: Klinikum am Bamberg
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
city: Berlin
country: Germany
facility: Helios Klinikum Berlin
city: Berlin
country: Germany
facility: Charite - Campus Charite Mitte
city: Berlin
country: Germany
facility: Charite University Hospital - Campus Virchow Klinikum
city: Biefeld
country: Germany
facility: Evangelisches Krankenhauus Bielfeld
city: Bonn
country: Germany
facility: Kinderklinik der Universitaet Bonn
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte
city: Celle
country: Germany
facility: Allgemeinen Krankenhaus Celle Kinderklinik
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Cologne
country: Germany
facility: Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl
city: Cologne
country: Germany
facility: Children's Hospital
city: Cottbus
country: Germany
facility: Carl - Thiem - Klinkum Cottbus
city: Datteln
country: Germany
facility: Vestische Kinderklinik Universitaetsklinik Witten/Herdecke
city: Detmold
country: Germany
facility: Klinikum Lippe - Detmold
city: Dresden
country: Germany
facility: Staedtisches Krankenhaus Dresden - Neustadt
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus
city: Duisburg
country: Germany
facility: Klinikum Duisburg
city: Erfurt
country: Germany
facility: Klinikum Erfurt
city: Erlangen
country: Germany
facility: Universitaets - Kinderklinik
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe Universitaet
city: Freiburg
country: Germany
facility: Universitaetskinderklinik - Universitaetsklinikum Freiburg
city: Giessen
country: Germany
facility: Kinderklinik
city: Goettingen
country: Germany
facility: Universitaetsklinikum Goettingen
city: Greiswald
country: Germany
facility: Universitats - Kinderklinik
city: Gummersbach
country: Germany
facility: Kreiskrankenhaus Gummersbach GMBH
city: Halle
country: Germany
facility: Universitaetsklinikum Halle
city: Hamburg
country: Germany
facility: University Medical Center Hamburg - Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitaets-Kinderklinik Heidelberg
city: Heide
country: Germany
facility: Kreskrankenhaus Kinderabteilung
city: Heilbronn
country: Germany
facility: SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
city: Herdecke
country: Germany
facility: Gemeinschaftskrankenhaus
city: Hildesheim
country: Germany
facility: Staedtisches Krankenhaus Hildesheim
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes
city: Idar-Oberstein
country: Germany
facility: Clinic for Bone Marrow Transplantation and Hematology and Oncology
city: Jena
country: Germany
facility: Universitaets - Kinderklinik
city: Kaiserslautern
country: Germany
facility: Municipal Hospital Complex of the University
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe gGmbH
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Kiel
country: Germany
facility: Staedtisches Krankenhaus Kiel
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein - Kiel Campus
city: Koblenz
country: Germany
facility: Klinikum Kemperhof Koblenz
city: Konstanz
country: Germany
facility: Klinik Konstanz
city: Krefeld
country: Germany
facility: Klinikum Krefeld GmbH
city: Landshut
country: Germany
facility: Kinderkrankenhaus St. Marien
city: Leipzig
country: Germany
facility: Universitaets - Kinderklinik
city: Ludwigshafen
country: Germany
facility: St. Annastift Krankenhaus
city: Luebeck
country: Germany
facility: Universitaets - Kinderklinik - Luebeck
city: Magdeburg
country: Germany
facility: Universitatsklinikum der MA
city: Mainz
country: Germany
facility: Johannes Gutenberg University
city: Mannheim
country: Germany
facility: Staedtisches Klinik - Kinderklinik
city: Marburg
country: Germany
facility: Universitaets - Kinderklinik
city: Minden
country: Germany
facility: Klinikum Minden
city: Moenchengladbach
country: Germany
facility: Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin
city: Muenster
country: Germany
facility: Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
city: Munich
country: Germany
facility: Krankenhaus Muenchen Schwabing
city: Munich
country: Germany
facility: Dr. von Haunersches Kinderspital der Universitaet Muenchen
city: Munich
country: Germany
facility: Staedtisches Krankenhaus Muenchen - Harlaching
city: Neubrandenburg
country: Germany
facility: Klinikum Neubrandenburg
city: Neuss
country: Germany
facility: Lukaskrankenhaus Neuss
city: Neuwied
country: Germany
facility: Marienhaus Klinikum St. Elisabeth Neuwied
city: Nuremberg
country: Germany
facility: Cnopf'sche Kinderklinik
city: Nuremberg
country: Germany
facility: Klinikum Nuernberg - Klinikum Sued
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Osnabruck
country: Germany
facility: Marien Hospital
city: Osnabrueck
country: Germany
facility: Paracelsus - Klinik Osnabrueck
city: Regensburg
country: Germany
facility: Klinik St. Hedwig-Kinderklinik
city: Rostock
country: Germany
facility: Kinderklinik - Universitaetsklinikum Rostock
city: Saarbrucken
country: Germany
facility: Saarbrucker Winterbergkliniken
city: Schwerin
country: Germany
facility: Klinikum Schwerin
city: Siegen
country: Germany
facility: Kinderklink Siegen Deutsches Rotes Kreuz
city: St. Augustin
country: Germany
facility: Johanniter-Kinderklinik
city: Stuttgart
country: Germany
facility: Olgahospital
city: Trier
country: Germany
facility: Krankenanstalt Mutterhaus der Borromaerinnen
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
city: Vechta
country: Germany
facility: St. Marienhospital - Vechta
city: Vechta
country: Germany
facility: Staedtisches Klinikum - Howedestrase
city: Wiesbaden
country: Germany
facility: Dr. Horst-Schmidt-Kliniken
city: Wilhelmshaven
country: Germany
facility: Reinhard-Nieter-Krankenhaus
city: Wolfsburg
country: Germany
facility: Klinikum der Stadt Wolfsburg
city: Wuerzburg
country: Germany
facility: Universitaets - Kinderklinik Wuerzburg
city: Wuppertal
country: Germany
facility: Helios Kliniken Wuppertal University Hospital
city: Jonkoping
country: Sweden
facility: Lanssjukhuset Ryhov
city: Aarau
country: Switzerland
facility: Kantonspital Aarau
city: Basel
country: Switzerland
facility: Universitaets-Kinderspital beider Basel
city: Locarno
country: Switzerland
facility: Ospedale "la Carita", Locarno
city: Lucerne 16
country: Switzerland
facility: Kinderspital Luzern
city: St. Gallen
country: Switzerland
facility: Ostschweizer Kinderspital
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: University Children's Hospital
Study officials:
affiliation: Klinikum Oldenburg
name: Hermann Mueller, MD
role: STUDY_CHAIR
References:
citation: Roth CL, Gebhardt U, Muller 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.
citation: Muller HL, Gebhardt U, Schroder S, Pohl F, Kortmann RD, Faldum A, Zwiener I, Warmuth-Metz M, Pietsch T, Calaminus G, Kolb R, Wiegand C, Sorensen N; study committee of KRANIOPHARYNGEOM 2000/2007. Analyses of treatment variables for patients with childhood craniopharyngioma--results of the multicenter prospective trial KRANIOPHARYNGEOM 2000 after three years of follow-up. Horm Res Paediatr. 2010;73(3):175-80. doi: 10.1159/000284358. Epub 2010 Mar 3.
citation: Mehren A, Ozyurt J, Zu Klampen P, Boekhoff S, Thiel CM, Muller HL. Self- and informant-rated apathy in patients with childhood-onset craniopharyngioma. J Neurooncol. 2018 Oct;140(1):27-35. doi: 10.1007/s11060-018-2936-z. Epub 2018 Jul 3.
citation: Ozyurt J, Muller HL, Warmuth-Metz M, Thiel CM. Hypothalamic tumors impact gray and white matter volumes in fronto-limbic brain areas. Cortex. 2017 Apr;89:98-110. doi: 10.1016/j.cortex.2017.01.017. Epub 2017 Feb 3.
citation: Daubenbuchel AM, Hoffmann A, Eveslage M, Ozyurt J, Lohle K, Reichel J, Thiel CM, Martens H, Geenen V, Muller HL. Oxytocin in survivors of childhood-onset craniopharyngioma. Endocrine. 2016 Nov;54(2):524-531. doi: 10.1007/s12020-016-1084-5. Epub 2016 Sep 1.
citation: Hoffmann A, Warmuth-Metz M, Lohle K, Reichel J, Daubenbuchel AM, Sterkenburg AS, Muller HL. Fusiform dilatation of the internal carotid artery in childhood-onset craniopharyngioma: multicenter study on incidence and long-term outcome. Pituitary. 2016 Aug;19(4):422-8. doi: 10.1007/s11102-016-0722-5.
citation: Ozyurt J, Thiel CM, Lorenzen A, Gebhardt U, Calaminus G, Warmuth-Metz M, Muller HL. Neuropsychological outcome in patients with childhood craniopharyngioma and hypothalamic involvement. J Pediatr. 2014 Apr;164(4):876-881.e4. doi: 10.1016/j.jpeds.2013.12.010. Epub 2014 Feb 6.
citation: Roth CL, Enriori PJ, Gebhardt U, Hinney A, Muller HL, Hebebrand J, Reinehr T, Cowley MA. Changes of peripheral alpha-melanocyte-stimulating hormone in childhood obesity. Metabolism. 2010 Feb;59(2):186-94. doi: 10.1016/j.metabol.2009.06.031. Epub 2009 Sep 18.