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Prospective Randomized Trial of Two Versus One Week Accelerated Radiotherapy (PRATO)
This study is comparing two different radiation therapy approaches for early breast cancer to see which one is better for patients. One group will receive radiation over one week (based on the FAST-FORWARD trial), and the other group will receive radiation over two weeks with an extra focused dose (called a "concomitant boost"). The study will look at how the treatments affect side effects, breast appearance, and cancer control in the breast. It also aims to find out if the two-week treatment does a better job at preventing cancer from coming back in the breast over the long term.
Radiotherapy: one week (Arm 1) 2600 cGy in 5 fractions whole breast radiotherapy over one week versus 2 weeks (Arm 2), 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy. In Arm 2, if no cavity is visible due to oncoplastic surgery, we will deliver 32 Gy to the whole breast only, without a boost. Hypothesis: A regimen of whole breast radiotherapy to 2600 in five fractions, the current UK standard for early breast cancer (Arm 2), is not inferior to 3200cGy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 1), in terms of acute toxicity and long-term fibrosis, breast cosmesis and local control at 2 and 5 years. It will also test the hypothesis of superior local control at 10 years in Arm 2 compared to Arm 1.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Brooklyn Methodist Hospital
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
New York-Presbyterian Weill Cornell Medical College
New York, New York, United States
Start Date
April 29, 2025
Primary Completion Date
December 31, 2030
Completion Date
December 31, 2040
Last Updated
July 25, 2025
400
ESTIMATED participants
Radiation therapy - 1 week
RADIATION
Radiation therapy - 2 weeks
RADIATION
Lead Sponsor
Weill Medical College of Cornell University
NCT04550494
NCT05673200
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