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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00238264 |
RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating young patients with gliomas.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas |
Estimated Enrollment: | 100 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline or 6 weeks after completion of study treatment and then at 2 and 5 years.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 100-150 patients will be accrued for this study over approximately 3-4.5 years.
Ages Eligible for Study: | 3 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* low-grade glioma, including any of the following:
Diffuse astrocytoma, including any of the following subtypes:
Meets any of the following criteria:
Progressive nonresectable disease
Must have received ≥ 1 course of prior chemotherapy (for patients < 10 years of age)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Joel M. Cherlow, MD | Todd Cancer Institute at Long Beach Memorial Medical Center |
Investigator: | Edward G. Shaw, MD | Wake Forest University |
Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
Study ID Numbers: | CDR0000445095, COG-ACNS0221, CIRB-05016 |
Study First Received: | October 12, 2005 |
Last Updated: | August 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00238264 History of Changes |
Health Authority: | Unspecified |
childhood oligodendroglioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma childhood low-grade cerebral astrocytoma |
recurrent childhood visual pathway and hypothalamic glioma untreated childhood cerebellar astrocytoma untreated childhood visual pathway and hypothalamic glioma |
Neuroectodermal Tumors Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma |
Glioma Central Nervous System Neoplasms Recurrence Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Nervous System Diseases |
Neoplasms, Nerve Tissue Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |