At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed WHO grade II supratentorial astrocytoma, oligodendroglioma, or oligoastrocytoma (with atypia allowed if no anaplastic features)
- ✓Must have ≥3 of the following: age ≥40, largest tumor diameter ≥6 cm, tumor crosses midline, astrocytoma-dominant subtype, or preoperative neurological dysfunction >1
- ✓Surgical biopsy or resection within past 12 weeks with tissue block or core biopsy available for MGMT analysis
- ✓Age 18 and over
- ✕No other low-grade glioma histologies (pilocytic astrocytoma, subependymal giant cell astrocytoma, subependymoma, pleomorphic xanthoastrocytoma, ganglioglioma, dysembryoplastic neuroepithelial tumor)
- ✕No high-grade gliomas (anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, anaplastic oligoastrocytoma)
- ✕No non-supratentorial tumors (optic nerve/chiasm, pons, medulla, cerebellum, spinal cord)
- ✕No evidence of leptomeningeal gliomatosis or disease progression to spinal/cranial meninges by MRI or CSF cytology (if symptomatic)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas
In Brief
A Phase 2 clinical trial evaluating Temozolomide and Radiation therapy for Brain and Central Nervous System Tumors. Completed, enrolled 136 participants across 47 sites in 2 countries.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with low-grade gliomas.
Study Details
Timeline
Interventions
Concurrent chemoradiotherapy temozolomide given 75 mg/m\^2 daily during radiotherapy for 6 weeks. Post-Radiation Temozolomide given 150 mg/m2 daily on days 1-5 every 28 days with cycle one beginning 28 days post-radiotherapy. In the absence of grade 3 or 4 adverse events, a single dose escalation to 200 mg/m2/day could be attempted for cycle 2 and, if tolerated, that dose should continue for all subsequent cycles. Cycles were repeated every 28 days (+/- 2 days) for a total of 12 cycles.
One treatment of 1.8 Gy given daily, 5 days per week (over 6 weeks) for a total dose of 54.0 Gy.