At a glance
ClinicalIndex Comparison Record- ✓Histopathologically confirmed glioblastoma or gliosarcoma
- ✓Diagnosis established by open biopsy or tumor resection (stereotactic biopsy alone not eligible)
- ✓Tumor must have a supratentorial component
- ✓At least one tissue block available for MGMT status analysis
- ✕Prior invasive malignancy within 3 years (except non-melanomatous skin cancer or carcinoma in situ)
- ✕Recurrent or multifocal malignant gliomas
- ✕Metastases below tentorium or beyond cranial vault
- ✕Prior chemotherapy or radiosensitizers for head/neck cancer; prior intratumoral therapy (Gliadel wafers); prior chemotherapy for other cancers is allowable
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma
In Brief
A Phase 3 clinical trial evaluating Concurrent temozolomide, Concurrent radiation therapy, and 2 other interventions for Brain and Central Nervous System Tumors. Completed, enrolled 1,173 participants across 351 sites in 2 countries.
Detailed Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma. PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.
Study Details
Timeline
Interventions
Daily oral temozolomide (75 mg/m2) up to 49 doses.
60 Gy in 2 Gy fractions
Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.