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TCCC: PARTIAL BREAST IRRADIATION CLINICAL TRIAL
Trinitas Cancer Center announces Partial Breast Irradiation Study for Women with Early Stage Breast Cancer (RTOG 0413 -- NSABP - National Surgical Adjuvant Breast and Bowel Project)
Trinitas CCC was recently approved as a Member of the prestigious Radiation
Therapy Oncology Group (RTOG) -- a national clinical trials cooperative
group of over 300 of the most qualified institutions across the United
States and Canada and funded by the National Cancer Institute (NCI). Only
approximately 10% of all radiotherapy facilities in the U.S. have been
approved for RTOG membership. Without delay, Trinitas CCC has begun its
first study in participation with researchers from the National Surgical
Adjuvant Breast and Bowel Project (NSABP) and the RTOG. The Phase III study
will determine whether limiting radiation therapy to only the tumor site
following lumpectomy (known as partial breast irradiation), is as effective
as irradiating the whole breast in the local management of early stage
breast cancer. Women in this study with early stage breast cancer will
undergo a lumpectomy and then be randomly assigned to partial breast
irradiation (PBI) therapy or whole breast irradiation (WBI) therapy. Over
four thousand women will participate in this study from approximately 150
sites in the United States, Canada, and Puerto Rico. Through this important
clinical research membership, Trinitas CCC patients now have access to high
quality multi-institutional protocols developed by many of today's leading
radiotherapy specialists.
According to Dr. Clarissa Febles Henson, Chair of Radiation Oncology and
principal investigator at Trinitas CCC, "Partial breast radiation has many
potentially promising benefits including decreased overall treatment time
and decreased radiation toxicity to the surrounding normal tissues,
including the ribs, lung and heart. Previous trials of partial breast
radiation were limited to women 50 years and over with negative lymph node
status, while this current trial is open to women 18 and older with tumors
up to 3.0 cm in size and up to 3 positive lymph nodes. It will be important
to determine if partial breast irradiation is equivalent to whole breast
irradiation in this patient population."
Women who are assigned to the WBI group will receive radiation therapy daily
on five days a week for five to seven weeks. Those assigned to the PBI group
will receive radiation therapy twice a day on five days over a one to two
week period.
Recent developments in PBI have resulted in several comparable and
reproducible techniques that are thought to be safe and are well tolerated.
It may also offer convenience since it is delivered over a shorter period of
time.
"This trial will determine the best options for women who wish to undergo
breast preserving treatment and the results will impact practice patterns
for the next several decades," said Dr. Henson.
For additional information on this clinical trial, contact Maria Serrano,
Clinical Research Manager at 908-994-8539.
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