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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) Southwest Oncology Group North Central Cancer Treatment Group Eastern Cooperative Oncology Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003375 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy combined with chemotherapy is more effective than radiation therapy alone in treating patients with low-grade glioma.
PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients with low-grade glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: lomustine Drug: procarbazine hydrochloride Drug: vincristine sulfate Procedure: radiation therapy |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase II Study of Observation in Favorable Low-Grade Glioma and a Phase II Study of Radiation With or Without PCV Chemotherapy in Unfavorable Low-Grade Glioma |
| Estimated Enrollment: | 252 |
| Study Start Date: | October 1998 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to tumor subtype (astrocytoma [mixed-astro dominant or equal astro/oligo mix] vs oligodendroglioma [mixed-oligo dominant]), age (younger than 40 vs at least 40), Karnofsky performance status (60-80% vs 90-100%), and contrast enhancement on preoperative scan (present vs absent). Patients with low-risk disease (younger than 40 years old whose tumors have been surgically removed) are assigned to arm I. Patients with high-risk disease (at least 40 years old or who have had incomplete tumor removal) are randomized to arm II or III.
Patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 252 patients will be accrued within 5.25 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No other low-grade histologies, including:
No presence of any high-grade glioma, including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
For high-risk patients:
Hepatic:
Renal:
Pulmonary:
Neurological:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Study Chair: | Edward G. Shaw, MD | Wake Forest University |
| Study Chair: | Geoffrey R. Barger, MD | Barbara Ann Karmanos Cancer Institute |
| Study Chair: | Jan C. Buckner, MD | Mayo Clinic |
| Study Chair: | Minesh P. Mehta, MD | University of Wisconsin, Madison |
More Information
| Study ID Numbers: | CDR0000066367, RTOG-9802, E-R9802, NCCTG-R9802, SWOG-R9802, RTOG-DEV-1012 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003375 |
| Health Authority: | United States: Federal Government |
|
adult oligodendroglioma adult diffuse astrocytoma adult pilocytic astrocytoma |
|
Astrocytoma Lomustine Vincristine Oligodendroglioma |
Procarbazine Glioma Central Nervous System Neoplasms Nervous System Neoplasms |
|
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Nervous System Diseases Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |
