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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group Southwest Oncology Group Eastern Cooperative Oncology Group NCIC Clinical Trials Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002569 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have anaplastic oligodendroglioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: lomustine Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | PHASE III INTERGROUP RANDOMIZED COMPARISON OF RADIATION ALONE VS PRE-RADIATION CHEMOTHERAPY FOR PURE AND MIXED ANAPLASTIC OLIGODENDROGLIOMAS |
Estimated Enrollment: | 292 |
Study Start Date: | July 1994 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified by age (under 50 vs 50 and over), Karnofsky performance status (60-70% vs 80-100%), and tumor grade (moderately vs highly anaplastic). Within 8 weeks after diagnostic surgery, patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline; at time of CT or MRI scans during study; and every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter after completion of study therapy.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 292 patients (146 per arm) will be accrued for this study within 5.4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma
Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2 or more anaplastic features, 1 of which must be frequent mitoses or endothelial proliferation
No evidence of spinal drop metastasis or spread 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:
Study Chair: | J. Gregory Cairncross, MD | London Regional Cancer Program at London Health Sciences Centre |
Study Chair: | Steven R. Alberts, MD | Mayo Clinic |
Study Chair: | Karen L. Fink, MD, PhD | Simmons Cancer Center |
Study Chair: | Richard M. Hellman, MD | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center |
Study Chair: | Normand Laperriere, MD, FRCPC | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000063603, RTOG-9402, CAN-NCIC-CE2, E-R9402, NCCTG-927252, SWOG-9402, INT-0149 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002569 History of Changes |
Health Authority: | United States: Federal Government |
adult anaplastic oligodendroglioma adult mixed glioma |
Lomustine Vincristine Central Nervous System Neoplasms Antimitotic Agents Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Tubulin Modulators |
Neuroepithelioma Oligodendroglioma Glioma Procarbazine Antineoplastic Agents, Phytogenic Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Nervous System Diseases Neoplasms, Nerve Tissue Vincristine Antimitotic Agents Central Nervous System Neoplasms Pharmacologic Actions Neuroectodermal Tumors Neoplasms |
Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Tubulin Modulators Oligodendroglioma Procarbazine Glioma Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Nervous System Neoplasms Neoplasms, Glandular and Epithelial |