At a glance
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Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
In Brief
A Phase 3 clinical trial evaluating temozolomide, DNA methylation analysis, and 4 other interventions for Brain and Central Nervous System Tumors. Active but no longer recruiting, targeting 751 participants across 132 sites in 12 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 whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma. PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.
Study Details
Timeline
Interventions
Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.
Prognostic factor analyses
Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
Quality of Life analysis will also be used to assess neurological deterioration free progression
Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule