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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
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.
Details
| Lead sponsor | Radiation Therapy Oncology Group |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | COMPLETED |
| Enrolment | 370 |
| Start date | 1998-10 |
| Completion | 2018-05-14 |
Conditions
- Brain and Central Nervous System Tumors
Interventions
- lomustine
- procarbazine hydrochloride
- vincristine sulfate
- radiation therapy
Primary outcomes
- Overall Survival — From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years or 80 deaths have been reported.