Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Diagnostic, Treatment Closed 18 and under at diagnosis Other GPOH-CRANIOPHARYNGIOMA-2000 EU-20537, NCT00258453

Objectives

Primary

1. Identify all applied therapy strategies in pediatric patients with craniopharyngioma.
2. Correlate relapse status with different therapy strategies/modality in these patients.
3. Determine the health status (i.e., ophthalmologic, neuropediatric, and endocrine findings) and the health-related quality of life of these patients after treatment.

Secondary

1. Determine the incidence of craniopharyngioma in pediatric patients.
2. Identify quality control measures for diagnosis and therapy in these patients.
3. Improve long-term care through a standardized follow-up program in these patients.
4. Determine the efficacy of endocrine substitution for postoperative hypopituitarism in these patients.
5. 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.
6. Determine the incidence and extent of eating disorders in these patients.

Entry 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

Prior/Concurrent Therapy:

Not specified

Patient Characteristics:

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Gesellschaft fuer Paediatrische Onkologie und Haematologie - Germany

Hermann Mueller, MD, Protocol chair		Ph: 49-441-403-2013 Email: mueller.hermann@klinikum-oldenburg.de

Registry Information
Official Title		Prospective, Multi-Center Survey Study of Children and Adolescents with Craniopharyngioma
Trial Start Date		2001-05-01
Trial Completion Date		2007-09-30 (estimated)
Registered in ClinicalTrials.gov		NCT00258453
Date Submitted to PDQ		2005-09-08
Information Last Verified		2007-10-14

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