Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma in Situ and Early Invasive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01266642|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2010
Last Update Posted : April 24, 2018
The goal of this clinical research study is to compare how 4 weeks of radiation treatment affects the breast to how 6 weeks of radiation treatment affects the breast.
Researchers also want to know about other side effects of radiation.
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 treatments.
Up to 288 participants will be enrolled in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Hypofractionated Whole Breast Irradiation Radiation: Conventionally Fractionated Whole Breast Irradiation||Phase 2|
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 started.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||288 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma in Situ and Early Invasive Breast Cancer|
|Actual Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Shorter radiation (Group 1), Hypofractionated Whole Breast Irradiation (HF-WBI)
Radiation: Hypofractionated Whole Breast Irradiation
42.56 Gy in 16 fractions delivered to the whole breast on consecutive treatment days.
Boost of 10 Gy in 4 fractions or 12.5 Gy in 5 fractions delivered on consecutive days beginning on treatment day following completion of whole breast irradiation.
Standard radiation (Group 2), Conventionally Fractionated Whole Breast Irradiation (CF-WBI)
Radiation: Conventionally Fractionated Whole Breast Irradiation
50 Gy in 25 fractions delivered to whole breast on consecutive treatment days.
Boost of 10 Gy in 5 fractions or 14 Gy in 7 fractions delivered on consecutive treatment days, beginning on treatment day following completion of whole breast irradiation.
- Percent Women with Adverse Cosmetic Scores at 3 Years [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266642
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Benjamin Smith, MD||M.D. Anderson Cancer Center|