Xoft, Inc. announced
the launch and of 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 Drs. Peter
Beitsch of the Dallas Breast Center and Timothy Nichols of 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(R) 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, MD,
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 fact that three physician organizations involved in the treatment
of breast cancer, ASBrS, ABS, and 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," added Dr.
Beitsch.
"Used to treat cancer for more than 100 years, radiation therapy is a
critical component in the treatment of cancer patients, proven to reduce
recurrence and potentially improve survival," said Rakesh Patel, MD,
Associate Professor, University of Wisconsin Medical School, Madison WI,
co-Principal Investigator of EXIBT, and Director at Large for the American
Brachytherapy Society. "Radiation therapy has been increasingly in the news
lately, with expanded regulation of radioactive materials announced by the
Nuclear Regulatory Commission. Combined with an increasing body of evidence
supporting accelerated partial breast irradiation, continued and multi-
disciplinary evaluation of Electronic Brachytherapy, a new method of
delivering non-isotope-based radiation treatment is timely and extremely
relevant.
"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," added
Dr. Patel.
The EXIBT Study oversight committee includes both radiation oncologists
and breast surgeons. Members of the oversight committee members
representing ABS and ACRO with a focus on radiation oncology are: Douglas
Arthur, MD, Virginia Commonwealth University, Frank Vicini, MD, William
Beaumont, David Wazer, MD, Tufts New England Medical Center and Brown
University, Arve Gillette, MD, US Oncology. Members of the oversight
committee members representing ASBrS with a focus on breast surgery are:
Michael Kinney, MD, Northwest Breast Care, Henry Kuerer, MD Anderson, Helen
Pass, MD, Columbia University, and Pat Whitworth, MD, Nashville Breast
Center and Vanderbilt University.
About Electronic Brachytherapy
Cleared for accelerated treatment of early stage breast cancer and
endometrial and rectal indications, the Axxent(R) Electronic Brachytherapy
System is now cleared for use in the treatment of other cancers or
conditions where radiation therapy is indicated. As a platform technology,
the Electronic Brachytherapy System is designed to address a variety of
oncological and non-oncological indications. Designed to deliver
electronic, X-ray-based radiation treatment, the proprietary Axxent
treatment platform can be used in virtually any clinical setting under the
supervision of a radiation oncologist. The Axxent System is designed to
deliver non-radioactive therapy directly to cancer sites with minimal
radiation exposure to surrounding healthy tissue. Eliminating the need for
heavily shielded environments, it gives radiation oncologists the
flexibility to deliver therapy in a broader range of clinical settings. As
a result, tens of thousands of patients will have greater access to therapy
that is delivered more easily and conveniently.
About Xoft, Inc.
Xoft is developing leading-edge new technologies for the practice of
radiation oncology through Electronic Brachytherapy, which utilizes
proprietary miniaturized X-ray tube technology. The Axxent(R) Electronic
Brachytherapy System, Xoft's first treatment system, is currently being
used in Accelerated Partial Breast Irradiation (APBI) for the treatment of
early- stage breast cancer. This solution provides a therapeutic dose of
intracavitary radiation directly to the region at risk without the complex
handling and resource logistics necessary when performing brachytherapy
using radioactive isotopes.
Axxent is a registered trademark of Xoft, Inc.
Xoft, Inc.
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