July 2, 2008 - Xoft Inc. launched the EXIBT Study (Electronic Xoft Intersociety Brachytherapy Trial), a national Electronic Brachytherapy patient registry under oversight from three national physician societies, the American Brachytherapy Society (ABS), the American Society of Breast Surgeons (ASBrS), and the American College of Radiation Oncology (ACRO).
The first patient was successfully enrolled and treated in the registry by Peter Beitsch, M.D., the Dallas Breast Center and Timothy Nichols, M.D., the Northpoint Cancer Center in Dallas, Texas.
With an enrollment goal of 400 patients, the objective of the multi-center study is to assess the long-term safety and efficacy of the Xoft Axxent Electronic Brachytherapy System for the treatment of early stage breast cancer patients. The primary endpoint is the measurement and quantification of skin and subcutaneous toxicities through five year follow-up. An important additional primary endpoint includes a quality of life questionnaire based on patient experience with this new form of radiation therapy. Secondary endpoints assess local-regional breast failure and patient survival through five years as well as device performance.
"From earlier diagnosis to decreased morbidities and treatment times and ultimately, improved survival, we have made great strides in treating women with breast cancer. For many women, post lumpectomy radiation therapy can now be completed in one week with brachytherapy compared to the 6-7 weeks required for external beam therapy," said Peter Beitsch, M.D., co-Principal Investigator of EXIBT and the surgeon for the first patient on the registry. Dr. Beitsch is director of the Dallas Breast Center and a Board Member of the American Society of Breast Surgeons. "With the innovative Electronic Brachytherapy System, physicians now have the ability to move breast brachytherapy out of the radiation bunker, offering women more comfortable, more accessible treatment with one of their caregivers actually present in the treatment room. Electronic brachytherapy allows for a much less anxiety-producing environment for patients who already have so much on their minds.
"The Electronic Brachytherapy patient registry will set new standards for gathering data by carefully correlating specific surgical and radiation dosimetric parameters with patient outcomes. The results should allow both breast surgeons and radiation oncologists to make more informed and collaborative treatment decisions, thereby resulting in better patient care by identifying women who might benefit most from this new technique," said Rakesh Patel, M.D., Associate Professor, University of Wisconsin Medical School, Madison WI, co-Principal Investigator of EXIBT, and Director at Large for the American Brachytherapy Society.
The EXIBT Study oversight committee includes both radiation oncologists and breast surgeons.
For more information: www.xoftinc.com