RTOG study likely treatment option for brain tumor patients like Sen. Kennedy

May 22 2008

A Radiation Therapy Oncology Group (RTOG) study which seeks to establish whether high-doses of the chemotherapy drug temozolomide after radiotherapy can improve outcome for patients with newly diagnosed malignant glioma is a possible consideration for Sen. Edward Kennedy (D-Mass.) and other patients with this type of brain tumor.

The ongoing study, conducted domestically by the RTOG, a clinical research component of the American College of Radiology (ACR), is enrolling approximately 1153 malignant glioma patients at 217 sites throughout the United States, Canada, Europe, and Israel including Massachusetts General Hospital in Boston.

"Researchers, both in the U. S. and abroad, have been very enthusiastic about this study," said Walter J. Curran Jr., M.D., the RTOG Group Chair, and the Lawrence W. Davis Professor and Chair of the Department of Radiation Oncology in the Emory School of Medicine and Chief Medical Officer of the Emory Winship Cancer Institute. "The rate of patient enrollment has exceeded our expectations, due in part, to the strong desire of the entire oncology community to find improved treatment options for patients with this serious disease. The trial is expected to close to patient accrual in mid-June, and researchers will begin analyzing the study data."

The goal of the study is find out if giving temozolomide for a longer time each month (compared to current practice) will improve the outcome for malignant glioma patients and what effects, if any, the longer drug schedule might have patients.

Since correlative laboratory studies have shown a link between tumor MGMT gene expression and treatment response, another goal of this trial is to examine the relationship between methylated MGMT status and temozolomide dose on survival. To find out which patients have the MGMT gene, a sample of tumor tissue from each patient is examined by a central laboratory prior to the randomized treatment assignment.

Enrolled patients take a daily dose of temozolomide orally during radiotherapy. At the completion of radiotherapy, patients are randomly assigned to receive either the standard treatment schedule consisting of temozolomide once a day for five days every four weeks for up to one year, or the longer schedule, consisting of temozolomide once a day for 21 days every four weeks for up to one year. Patients receive an MRI or CT scan at regular intervals to assess tumor size and treatment effect. The researchers will keep track of the patient's medical condition for the rest of his or her life.

The European Organisation for Research and Treatment of Cancer (EORTC) is a cosponsor of this four-year, multicenter trial, funded by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH).

The RTOG-led study, RTOG 0525/EORTC 26052_22053: Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose-Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma, builds upon the work of Mark R. Gilbert, M.D., the RTOG study chair from the University of Texas M.D. Anderson Cancer Center, and the work of Roger Stupp, M.D., University of Lausanne in Switzerland, with the EORTC and the National Cancer Institute of Canada.

The RTOG and the EORTC have played key roles in the development of new cancer treatments for several decades. The goals of the two groups are to increase survival and improve quality of life for patients diagnosed with cancer.

Click to read the RTOG 0525 patient brochure.(PDF)

http://www.rtog.org