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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• Women status post segmental mastectomy.

• If unilateral, pT1-2 breast cancer excised with negative margins.

• If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.

• Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx or sentinel node negative.

• Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).

• Women with previous contralateral treated breast cancer can be enrolled in the trial.

Locations
United States
New York
Brooklyn Methodist Hospital
RECRUITING
New York
New York Presbyterian Hospital
RECRUITING
New York
New York-Presbyterian Weill Cornell Medical College
RECRUITING
New York
Contact Information
Primary
Fabiana Gregucci, MD
fgr4002@med.cornell.edu
6469623110
Backup
Fereshteh Talebi, MD
fet4007@med.cornell.edu
6467027830
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2040-12-31
Participants
Target number of participants: 400
Treatments
Experimental: ARM 1-2600 cGy in 5 fractions whole breast radiotherapy
Patients randomized to ARM 1 will receive 2600 cGy in 5 fractions whole breast radiotherapy over one week
Experimental: ARM 2- 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy
Patients randomized to ARM 2 will receive 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy.
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov