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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 National Cancer Institute of Canada |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002569 |
Purpose
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 |
|
Brain and Central Nervous System Tumors |
Drug: lomustine Drug: procarbazine hydrochloride Drug: vincristine sulfate Procedure: radiation therapy |
Phase III |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Vincristine sulfate Vincristine Lomustine Procarbazine hydrochloride Procarbazine |
| 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.
Eligibility
| 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:
Contacts and Locations![]() |
Show 95 Study Locations |
| Radiation Therapy Oncology Group |
| National Cancer Institute (NCI) |
| North Central Cancer Treatment Group |
| Southwest Oncology Group |
| Eastern Cooperative Oncology Group |
| National Cancer Institute of Canada |
| 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 |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000063603, RTOG-9402, CAN-NCIC-CE2, E-R9402, NCCTG-927252, SWOG-9402, INT-0149 |
| First Received: | November 1, 1999 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002569 |
| Health Authority: | United States: Federal Government |
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