The purpose of this study is to determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with breast cancer
Hypo-fractionation (several large fractions as the only radiation treatment) for breast cancer irradiation was common in the forties and 50s and, while very successful in achieving tumor control, was found to leave significantly inferior cosmetic results due to severe fibrosis and telangiectasia compared to those obtained with multiple fraction regimens (38-40). These complications were due to the use of very large fields, with the inclusion of a large proportion of uninvolved skin and tissue surrounding the tumor. Based on these assumptions, a few large fractions can be safely delivered to breast cancers provided that 1) the target volume is sufficiently small and 2) the radiation technique assures maximum sparing of the surrounding normal tissue. Conformal RT to the tumor bed of T1 breast cancers satisfies both requirements.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
All patients will be treated with 6 Gy (measure of radiation dose) /fraction (each radiation session) delivered in 5 fractions over a 2 week period for a total dose of 30 Gy. In addition to routine care, patients may receive antihormonal drugs as part of your base line treatment.
NYU Perlmutter Cancer Center
New York, New York, United States
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 5 years
TGF-beta 1 determinations
Blood specimens will be collected by venipuncture, before starting treatment, immediately after the last treatment fraction
Time frame: From baseline to up to 4 weeks
Ultrasound for target localization
Ultrasound is ideal for imaging soft tissues unobstructed by bone and has been used successfully in conjunction with the treatment of prostate cancer to verify compliance between the daily location of the prostate and the planned location with respect to the treatment linear accelerator. By using ultrasound to image the post-operative tumor bed of the breast in "real-time", the operator may automatically align the tumor bed with treatment machine on each day of treatment
Time frame: up to 4 weeks
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