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Clinical Trial Summary

To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide


Clinical Trial Description

A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Glioma
  • Newly Diagnosed Supratentorial Malignant Glioma

NCT number NCT00283543
Study type Interventional
Source Kentuckiana Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 2002
Completion date April 2008