Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

German Society for Pediatric Oncology and Hematology GPOH gGmbH

Status: Completed

Conditions: Brain and Central Nervous System Tumors; Perioperative/Postoperative Complications; Psychosocial Effects of Cancer and Its Treatment; Weight Changes; Long-term Effects Secondary to Cancer Therapy in Children

Treatments: Procedure: quality-of-life assessment; Procedure: conventional surgery; Procedure: magnetic resonance imaging; Radiation: radiation therapy; Other: metabolic assessment; Procedure: management of therapy complications; Procedure: biopsy; Other: physiologic testing; Procedure: computed tomography; Procedure: psychosocial assessment and care

Study type: Interventional

Funder types: Other

Identifiers

NCT00258453

EU-20537

CDR0000450768 (Registry Identifier)

GPOH-CRANIOPHARYNGIOMA-2000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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