Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma - Full Text View

Purpose

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.

Condition	Intervention
Brain and Central Nervous System Tumors Long-Term Effects Secondary to Cancer Therapy in Children Perioperative/Postoperative Complications Psychosocial Effects/Treatment Quality of Life Weight Changes	Procedure: biopsy Procedure: computed tomography Procedure: conventional surgery Procedure: magnetic resonance imaging Procedure: management of therapy complications Procedure: metabolic abnormality assessment Procedure: physiologic testing Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: radiation therapy

MedlinePlus related topics:

Cancer MRI Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	120
Study Start Date:	May 2001
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258453

Show 109 Study Locations

Sponsors and Collaborators

Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany

Investigators


Study Chair:	Hermann Mueller, MD	Klinikum Oldenburg

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000450768, GPOH-CRANIOPHARYNGIOMA-2000, EU-20537
First Received:	November 22, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00258453
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

quality of life

psychosocial effects/treatment

long-term effects secondary to cancer therapy in children

perioperative/postoperative complications

weight changes

childhood craniopharyngioma

Study placed in the following topic categories:

Body Weight

Neuroectodermal Tumors

Signs and Symptoms

Postoperative Complications

Neoplasms, Germ Cell and Embryonal

Body Weight Changes

Craniopharyngioma

Neoplasm Metastasis

Neuroepithelioma

Quality of Life

Central Nervous System Neoplasms

Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplastic Processes

Neoplasms

Neoplasms by Site

Pathologic Processes

Neoplasms by Histologic Type

Nervous System Diseases

Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00258453