Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma in Situ and Early Invasive Breast Cancer
Study Questionnaire and Photographs:
If you agree to take part in this study, you will complete questionnaires about your general
health and how your breast currently looks and feels. This should take about 15 minutes to
complete. Photographs will also be taken of your breast and your doctor will rate the way
your breast looks before you begin receiving radiation. You will not be able to be
identified in the photographs. The photographs will be kept as part of your medical record.
You will also have a physical exam and your medical history will be recorded.
You will then be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1
will receive shorter radiation. Group 2 will receive standard radiation.
For shorter radiation (Group 1), you will receive about 3 weeks of radiation (16 treatments)
to the entire breast. You will also have 4-5 additional treatments of radiation as a
"boost". The boost will be delivered to the part of the breast where the disease first
For standard radiation (Group 2), you will receive about 5 weeks of radiation (25
treatments) to the entire breast. You will also have 5-7 additional treatments of radiation
as a boost to the part of the breast where the disease started.
While you are receiving radiation, you will be asked about any side effects you may be
having each week.
You will return to the clinic for follow-up visits 6 months and 1, 2, 3, 4, and 5 years
after you have finished receiving radiation. At each follow-up visit, you will fill out the
study questionnaire, more photographs will be taken of your breast, and you will be asked
about any side effects you may be having. You will also have a physical exam and your
medical history will be recorded.
Length of Study:
After the 5-year follow-up visit, you will be off study.
This is an investigational study. Both the standard and the shorter radiation courses are
FDA-approved in patients with breast cancer. The goal of this study is to compare the 2
Up to 288 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent Women with Adverse Cosmetic Scores at 3 Years
Comparison of patient-reported cosmetic outcomes using Breast Cancer Treatment Outcomes Scale (BCTOS): 1) Hypofractionated whole breast irradiation (HF-WBI) versus 2) Conventionally fractionated whole breast irradiation (CF-WBI). Number of women with adverse cosmetic scores at 3 years after completion of breast conserving surgery, as determined by the patient-reported BCTOS where a score of 2.5 or more indicates an adverse cosmetic outcome.
Benjamin Smith, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|