Newswise — Thanjavur S. Ravikumar, M.D., chair, Geisinger Health System Oncology, director of the Center for Surgical Innovation and chief quality officer for Surgery and Interventional Procedures, will launch a Phase III trial of the potentially lifesaving HEAT Study, an international clinical trial for those with hepatocellular carcinoma (HCC) or primary liver cancer. HCC is the third leading cause of cancer deaths globally and is one of the fastest rising cancers in the United States.
A nationally renowned surgical oncologist who joined Geisinger in January, Dr. Ravikumar is the principal investigator for the HEAT Study in North America. The HEAT Study, which is sponsored by Celsion Corp, will determine the effectiveness of using radiofrequency ablation (RFA) in combination with ThermoDox®, a heat-sensitive drug that releases an anti-cancer agent when exposed to the heat of (RFA). RFA is a tumor-targeting technique involving the insertion of a hollow needle directly into the tumor, through which electrical energy is delivered to heat and destroy cancer cells.
A Phase I study, which was conducted from 2007 to mid-2008, determined that ThermoDox® was safe and appropriate to use in combination with RFA.
Phase III will study 600 patients; half will receive ThermoDox® with RFA, while the other participants only will receive RFA. The study will evaluate the treatment's effectiveness in terms of tumor control, as well as patients' survival and quality of life.
"HCC is a fast-moving, lethal cancer. The HEAT Study offers hope to those facing an uncertain future," said Dr. Ravikumar. "This novel 'double-targeted' approach of RFA and ThermoDox® allows physical destruction and high-dose local drug delivery simultaneously, thereby enabling us to find new clinical options for our patients with this lethal cancer."
The HEAT Study is being conducted at eight sites nationwide.
About Geisinger Health SystemFounded in 1915, Geisinger Health System is one of the nations largest integrated health services organizations. Serving more than 2.6 million residents throughout central and northeastern Pennsylvania, the physician-led organization is a nationally recognized leader in the use of electronic health records, patient access and engagement in their healthcare, and in medical education for the next generation. Geisinger is comprised of three medical center campuses, a 740-member group practice, a not-for-profit health insurance company and research that extends across our large system- all dedicated to creating new models for scientific discovery, quality patient care, and successful clinical outcomes. Geisinger's Weis Center, Center for Health Research and Center for Clinical Studies include basic science, population-based and clinical trials research, complemented by collaborative relationships with top academic centers. Geisinger Ventures, the system's for profit entrepreneurial arm, seeks and promotes opportunities to speed the delivery of medical innovation to benefit patients. For more information, visit www.geisinger.org.
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