Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04175210

Patient View

This study involves women post-segmental mastectomy with Stage 0, T1-T2, N0 breast cancer. Participants are randomized to receive either 15 fractions of whole breast radiotherapy with a tumor bed boost (Arm 1) or 10 fractions (Arm 2). Eligibility requires negative margins and clinically or pathologically node-negative status. The trial compares standard and accelerated radiation schedules.

Patient Parameters

Program Overview

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 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).

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

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