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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00401037 |
Purpose
RATIONALE: Radiation therapy directed at the central nervous system may change the way blood vessels form in young patients. It may also change brain function, the ability to see and hear, and the patient's quality of life. A study that evaluates young patients for several years after undergoing CNS radiation therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying the side effects of radiation therapy in young patients with CNS tumors.
| Condition | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors Cognitive/Functional Effects Long-term Effects Secondary to Cancer Therapy in Children Neurotoxicity Psychosocial Effects of Cancer and Its Treatment Radiation Toxicity |
Genetic: polymorphism analysis Genetic: proteomic profiling Other: bioluminescence Other: immunoenzyme technique Other: laboratory biomarker analysis Other: mass spectrometry Other: physiologic testing Procedure: cognitive assessment Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Official Title: | An Exploratory Study of Biologic and Pathophysiologic Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors |
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| Principal Investigator: | Katherine Warren, MD | NCI - Pediatric Oncology Branch |
More Information
| Study ID Numbers: | CDR0000500489, NCI-06-C-0219, NCI-P6810 |
| Study First Received: | November 16, 2006 |
| Last Updated: | July 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00401037 History of Changes |
| Health Authority: | Unspecified |
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cognitive/functional effects neurotoxicity radiation toxicity psychosocial effects of cancer and its treatment long-term effects secondary to cancer therapy in children childhood meningioma childhood spinal cord neoplasm childhood central nervous system germ cell tumor childhood high-grade cerebral astrocytoma childhood low-grade cerebral astrocytoma childhood choroid plexus tumor childhood craniopharyngioma childhood infratentorial ependymoma |
childhood supratentorial ependymoma childhood oligodendroglioma childhood atypical teratoid/rhabdoid tumor recurrent childhood brain stem glioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma newly diagnosed childhood ependymoma recurrent childhood ependymoma recurrent childhood medulloblastoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood visual pathway and hypothalamic glioma recurrent childhood brain tumor |
|
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Neurotoxicity Syndromes Nervous System Diseases |
Poisoning Neoplasm Metastasis Disorders of Environmental Origin Central Nervous System Neoplasms Nervous System Neoplasms |
