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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004259 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared to radiation therapy and carmustine or lomustine in treating patients with anaplastic astrocytoma or mixed gliomas.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: carmustine Drug: lomustine Drug: temozolomide Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Randomized Study (Phase I Closed) of Radiation Therapy and Temozolomide Versus Radiation Therapy and Nitrosourea for Anaplastic Astrocytoma And Mixed Anaplastic Oligoastrocytoma (Astrocytoma Dominant) |
Estimated Enrollment: | 474 |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), Karnofsky performance status (60-80% vs 90-100%), and prior surgery (biopsy only vs resection).
Phase I (closed as of 8/15/02)
Phase III
Patients are randomized to 1 of 2 treatment arms.
Chemotherapy repeats every 4 weeks for a total of 12 courses.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for phase I of the study and then a total of 454 patients (227 per treatment arm) will be accrued for phase III of the study within 4 years. (Phase I closed as of 8/15/02)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the following:
Mixed oligodendroglial/astrocytic tumors
No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Susan M. Chang, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study Chair: | Kurt A. Jaeckle, MD | Mayo Clinic |
Study Chair: | Peter Bushunow, MD | Lipson Cancer and Blood Center at Rochester General Hospital |
Study ID Numbers: | CDR0000067512, RTOG-9813, ECOG-R9813, NCCTG-RTOG-9813 |
Study First Received: | January 28, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004259 History of Changes |
Health Authority: | United States: Federal Government |
adult anaplastic astrocytoma adult mixed glioma |
Astrocytoma Carmustine Lomustine Central Nervous System Neoplasms Temozolomide Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Carmustine Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Temozolomide Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |