RecruitingPhase 3NCT06960707

Two Versus One Week Breast Radiotherapy (RT)

Prospective Randomized Trial of Two Versus One Week Accelerated Radiotherapy (PRATO)


Sponsor

Weill Medical College of Cornell University

Enrollment

400 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is comparing two different lengths of radiation therapy after breast-conserving surgery (lumpectomy): a 1-week course versus a 2-week course. Both are shorter than the traditional 5–6 week approach. Researchers want to see if the 1-week course is just as effective and safe as the 2-week schedule. **You may be eligible if...** - You are a woman who has had a lumpectomy for early-stage breast cancer (T1–T2) with clear margins - Your cancer has not spread to lymph nodes, or only a small number of nodes were involved - You have ductal carcinoma in situ (DCIS) with clear surgical margins - You have had previous cancer in the other breast but it was treated **You may NOT be eligible if...** - You previously received radiation to the same breast - It has been more than 90 days since your surgery (unless you had chemotherapy afterward) - It has been more than 60 days since your last chemotherapy - You are male - You have a severe autoimmune disease currently being treated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation therapy - 1 week

2600 cGy whole breast radiotherapy in five fractions (Arm 1) over 1 week

RADIATIONRadiation therapy - 2 weeks

3200 cGy whole breast radiotherapy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 2) over 2 weeks. 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.


Locations(3)

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

View Full Details on ClinicalTrials.gov

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NCT06960707


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