Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00258453
First received: November 22, 2005
Last updated: August 1, 2013
Last verified: October 2007
  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 of Cancer and Its Treatment
Weight Changes
Other: metabolic assessment
Other: physiologic testing
Procedure: biopsy
Procedure: computed tomography
Procedure: conventional surgery
Procedure: magnetic resonance imaging
Procedure: management of therapy complications
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Radiation: radiation therapy

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective, Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma

Resource links provided by NLM:


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

Estimated Enrollment: 120
Study Start Date: May 2001
Study Completion Date: September 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00258453     History of Changes
Other Study ID Numbers: GPOH-CRANIOPHARYNGIOMA-2000, CDR0000450768, EU-20537
Study First Received: November 22, 2005
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
psychosocial effects of cancer and its treatment
long-term effects secondary to cancer therapy in children
perioperative/postoperative complications
weight changes
childhood craniopharyngioma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Postoperative Complications
Craniopharyngioma
Adamantinoma
Body Weight Changes
Neoplasms by Site
Neoplasms
Nervous System Diseases
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014