At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed unifocal anaplastic astrocytoma or mixed glioma with oligodendroglial component ≤25%
- ✓No vascular proliferation and necrosis
- ✓Tumor not predominantly located in posterior fossa (brainstem or cerebellum)
- ✓Eligible if prior low-grade astrocytoma now anaplastic with no prior radiotherapy or chemotherapy
- ✕Spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges
- ✕Prior chemotherapy
- ✕Prior radiotherapy to brain or head and neck
- ✕Pre-existing lung disease that would preclude administration of carmustine/lomustine or therapy completion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized Study (Phase I Closed) of Radiation Therapy and Temozolomide Versus Radiation Therapy and Nitrosourea for Anaplastic Astrocytoma And Mixed Anaplastic Oligoastrocytoma (Astrocytoma Dominant)
In Brief
A Phase 3 clinical trial evaluating BCNU 80mg/m2, TMZ 200mg/m2, and 6 other interventions for Brain and Central Nervous System Tumors. Completed, enrolled 230 participants across 92 sites.
Detailed Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared to radiation therapy and carmustine or lomustine in treating patients with anaplastic astrocytoma or mixed gliomas.
Study Details
Timeline
Interventions
BCNU 80 mg/m2 will be administered as an intravenous infusion on days 1, 2, and 3 of the first week of radiotherapy and on days 56, 57, and 58, then every eight weeks for four more cycles for a total of 6 cycles (maximum BCNU dose 1440 mg/m2).
200 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat every 28 days for a total of 12 cycles.
1.8 Gy fractions (to isocenter), 1 fraction per day, 5 days per week to a dose of 59.4 Gy in 33 fractions.
CCNU at 130 mg/m2 orally every 8 weeks for a total of 6 cycles. Administered on day 1 of the first week of radiotherapy and on day 56, then administered every 8 weeks for four more cycles for a total of 6 cycles.
BCNU 150 mg/m2 will be administered as an intravenous infusion on day 5 of radiotherapy, and it will be repeated every eight weeks for a total of six cycles (maximum total BCNU dose 900 mg/m2).
BCNU 200 mg/m2 will be administered as an intravenous infusion on day 1 of radiotherapy and will be repeated every six weeks for a total of 6 cycles (maximum BCNU dose 1200 mg/m2).
150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 6-week cycles
150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 8-week cycles