Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Last updated: June 27, 2025
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Breast Cancer

Cancer

Treatment

Radiation therapy - 3 weeks

Radiation therapy - 2 weeks

Clinical Study ID

NCT04175210
19-07020533
  • Ages 19-90
  • Female

Study Summary

Patients with Stage 0 ductal carcinoma in situ (Tis (DCIS), Stage T1-T2, lymph node negative(N0) breast cancers will be randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1, standard) versus 10 fractions (Arm 2, experimental).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 excisedwith negative margins.

  • Clinically N0 or pN0 or sentinel node negative

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

  • Women with previous contralateral breast cancer.

Exclusion

Exclusion Criteria:

  • Previous radiation therapy to the ipsilateral breast.

  • 90 days from last surgery, unless s/p adjuvant chemotherapy

  • 60 days from last chemotherapy

  • Male breast cancer

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Radiation therapy - 3 weeks
Phase: 3
Study Start date:
November 21, 2019
Estimated Completion Date:
June 30, 2030

Connect with a study center

  • Brooklyn Methodist Hospital - NewYork Presbyterian

    New York, New York 11215
    United States

    Site Not Available

  • New York Presbyterian Hospital - Queens

    New York, New York 11355
    United States

    Site Not Available

  • New York Presbyterian Hospital at Lower Manhattan Cancer Center

    New York, New York 10007
    United States

    Site Not Available

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