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(Other current news and archived releases from the Jefferson Health System are available.)

RTOG Launches Landmark Brain Tumor Study

Philadelphia, PA – February 16, 2006 – The Radiation Therapy Oncology Group (RTOG), in conjunction with the European Organization for Research and Treatment of Cancer (EORTC), recently launched a landmark study to determine if the administration of high-dose temozolomide after radiotherapy leads to improved outcome for newly diagnosed glioblastoma patients. The study is the first international brain tumor trial coordinated by a research organization from the United States. Patients will be entered from RTOG member facilities in the US and Canada, and from EORTC members across Europe.

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, MD, the RTOG study chair from the University of Texas M.D. Anderson Cancer Center, and the work of Roger Stupp, MD, University of Lausanne in Switzerland, with the EORTC and the National Cancer Institute of Canada. Their phase I and phase II research showed an improvement in survival with adjuvant temozolomide and demonstrated that a dose- intensive treatment schedule is well-tolerated. This phase III trial will examine the benefit of dose-intensive temozolomide in a multi-center, international prospective clinical trial. Additionally, since correlative laboratory studies have shown a link between MGMT expression and treatment response, this trial will examine the relationship between methylated MGMT status and temozolomide dose on survival.

Newly diagnosed glioblastoma patients will be registered on this study after surgery but prior to the start of radiotherapy. Tissue samples will be sent to a central pathologist for histologic confirmation and MGMT status analysis. Temozolomide will be taken daily during radiotherapy. At the completion of concurrent radiotherapy and temozolomide, patients will be stratified by their RPA class and MGMT status and 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 dose-intensive schedule, consisting of temozolomide once a day for 21 days every four weeks for up to one year. Approximately 830 patients will be entered on this study.

For more information please contact the RTOG study chair, Mark R. Gilbert, MD at (713) 792-4008 or

* Up to 12 cycles if the patient demonstrates continued improvement on MRI scan, decreasing corticosteroid requirement, improvement in performance status, or improvement in neurologic function.

Select Eligibility Criteria

.. Histopathologically proven diagnosis of glioblastoma multiforme.

.. Patients must have at least 1 block of tissue available for analysis of MGMT status; fresh frozen tumor tissue acquisition is encouraged.

.. The tumor must have a supratentorial component.

.. Patients must have recovered from the effects of surgery, postoperative infection, and other complications before study registration.

.. A diagnostic contrast-enhanced MRI or CT scan (if MRI is not available) of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days prior to study registration.

.. Therapy must begin 5 weeks after surgery.

.. Karnofsky performance status of 60.