Xoft, a brachytherapy device developer, has enrolled and treated its first patient in its national electronic brachytherapy patient registry under the oversight from the American Brachytherapy Society (ABS), the American Society of Breast Surgeons (ASBrS) and the American College of Radiation Oncology (ACRO).
With an enrollment goal of 400 patients, the objective of the multi-center the EXIBT (Electronic Xoft Intersociety Brachytherapy Trial) 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 first patient was successfully enrolled and treated in the registry by Peter Beitsch, MD, of the Dallas Breast Center and Timothy Nichols, MD, of the Northpoint Cancer Center in Dallas.
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, according to the researchers.
“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 six to seven weeks required for external beam therapy,” said Beitsch, co-principal investigator of the study. “With the innovative electronic brachytherapy system, physicians now have the ability to move breast brachytherapy out of the radiation bunker.”
“The fact that three physician organizations involved in the treatment of breast cancer, the ASBrS, the ABS and the ACRO, have agreed to jointly provide oversight for the electronic brachytherapy patient registry speaks to the multi-disciplinary nature of breast brachytherapy treatment decisions and the potential impact this new method of delivering non-radioactive, non-isotope-based radiation treatment may have on patients,” Beitsch said.
The EXIBT study oversight committee includes both radiation oncologists and breast surgeons, according to the Sunnyvale, Calif.-based Xoft.