Active — Not RecruitingPhase 3

Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

United States397 participantsStarted 2019-11-21

Plain-language 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).

Who can participate

Age range19 Years – 90 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 excised with 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 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

What they're measuring

Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 10-fraction Arm Compared to Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 15-fraction Arm Evaluated up to 1-month Post-radiation Treatment

Timeframe: up to 1-month post-radiation treatment

Trial details

NCT IDNCT04175210

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-15

Results submitted2026-04-09

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