The American College of Radiology's Radiation Therapy Oncology Group (RTOG) has launched a study with its European counterpart to determine if the administration of high-dose temozolomide after radiotherapy leads to improved outcome for newly diagnosed glioblastoma patients.
The Reston, VA, group is working with the European Organization for Research and Treatment of Cancer (EORTC) on the study, which is the first international brain tumor trial coordinated by a research organization from the U.S. It will include more than 800 total patients from RTOG member facilities in the U.S. and Canada, and from EORTC members across Europe.
The study hopes to follow up on laboratory studies that have shown a link between tumor MGMT gene expression and treatment response. The trial will examine the benefit of large doses of temozolomide after radiotherapy through a multicenter, international prospective clinical trial.
Newly diagnosed glioblastoma patients will be registered in the study after surgery but before the start of radiotherapy. Tumor tissue samples will be sent to a central pathology laboratory for histologic confirmation and MGMT status analysis.
Patients will take a daily dose of temozolomide orally during radiotherapy. At the completion of radiotherapy, patients will be randomly assigned to receive either the standard treatment schedulee, consisting of temozolomide once a day for five days every four weeks for up to one year, or the dose-intensive schedule, consisting of temozolomide once a day for 21 days every four weeks for up to one year.
By AuntMinnie.com staff writers
March 17, 2006
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