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TRINITAS COMPREHENSIVE CANCER CENTER ENGAGED IN COMPARATIVE DRUG STUDY
Study examines Cognitive Dysfunction in Whole-Brain Radiotherapy Patients

Trinitas Comprehensive Cancer Center (Trinitas CCC) is currently participating in a research study to compare the effects of a drug called Memantine to a placebo in order to determine whether cognitive function, such as memory, is preserved in patients who receive whole-brain radiotherapy for treatment of cancer that has metastasized or spread to their brain. The Radiation Therapy Oncology Group (RTOG) - a national clinical trials cooperative group whose membership includes Trinitas CCC - is conducting this study with funding from the National Cancer Institute.

Radiation therapy, which involves daily administration of radiation to the entire brain, is often referred to as whole-brain radiotherapy. This treatment approach uses radiation to destroy cancer cells in patients who have brain metastases - tumors that spread to the brain which originated in tissues or organs elsewhere in the body. Over a period of several weeks, whole-brain radiotherapy is often successful in substantially shrinking the brain metastases and, in turn, alleviating the patient's symptoms.

"However, this treatment option often causes cognitive side effects, such as memory loss, which become increasingly apparent over time," notes Dr. Clarissa Febles Henson, Chair of Radiation Oncology at Trinitas CCC. "Because there is limited data on neurocognitive function, researchers are unsure whether this decline in memory and thinking abilities stems from chemotherapy, radiation, the cancer itself, or all three."

Memantine, which is currently prescribed for several types of dementia but is investigational in this study, will be given to 536 patients nationwide who have agreed to participate in this double-blind, randomized trial. During the typical three-week course of whole-brain radiotherapy, Memantine is orally administered to the patient. Over a 24-week duration, a series of cognitive tests are conducted to measure the patient's memory and thinking abilities. Patients are monitored carefully throughout the study, undergoing physical and neurologic examinations, blood tests, and MRIs of the brain. Upon completion of the study treatment, patients will be required to visit their doctor for regularly scheduled follow-up exams for the duration of their lives.

At the conclusion of this trial, researchers and physicians expect to discover if taking Memantine during and after whole brain radiotherapy helps patients maintain their cognitive functions. Doctors remain optimistic that this drug could prevent thinking problems which frequently occur after undergoing whole-brain radiotherapy.

"It is very exciting for Trinitas Comprehensive Cancer Center to have this trial available. There is no other randomized trial that is currently looking at drugs to improve memory during radiation," says Dr. Henson.

For more information about the study or the sponsoring organization, RTOG, visit their Web site at www.rtog.org.


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