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
- Identify the overall survival of low-risk adult patients with supratentorial low-grade
glioma who are observed postoperatively.
- Compare the overall survival of high-risk adult patients with supratentorial low-grade
glioma who receive postoperative external beam radiotherapy with or without
procarbazine, lomustine, and vincristine (PCV) chemotherapy.
- Compare the toxic effects of postoperative radiotherapy with or without PCV
chemotherapy in patients with unfavorable low-grade glioma.
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.
- Arm I (low-risk patients): Patients are observed. Patients may receive treatment if
- Arm II (high-risk patients): Patients receive daily external beam radiotherapy 5 days a
week for 6 weeks.
- Arm III (high-risk patients): Patients receive radiotherapy as in arm II followed by
chemotherapy 1 month later. Chemotherapy consists of oral lomustine on day 1,
vincristine IV on days 8 and 29, and oral procarbazine on days 8-21. Each course of
chemotherapy lasts 8 weeks. Patients may receive up to 6 courses of chemotherapy.
Patients are followed every 4 months for 1 year, every 6 months for 2 years, and then
PROJECTED ACCRUAL: Approximately 252 patients will be accrued within 5.25 years.
Allocation: Randomized, Primary Purpose: Treatment
Edward G. Shaw, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government