Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

NCT04175210 | Active Not Recruiting Phase 3 Results DMC FDA Device

• 1 other identifier: 19-07020533
• Study Type: interventional
• Target: 397
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Proportion of grade ≥ 2 of acute toxicity defined according to the Common Terminology Criteria for Adverse Events (CTCAEs) - version 5.0, on the 10-fraction arm compared to the rate on the 15-fraction arm will be measured, up to 1-month post-radiation treatment.

  up to 1-month post-radiation treatment

Secondary Outcomes (6)

• Proportion of Patients With Local Breast Cancer Control on the 10-fraction Arm Compared to Proportion of Patients With Local Breast Cancer Control on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment

  2-3 years

• Proportion of Patients With Local Breast Cancer Control on the 10-fraction Arm Compared to Proportion of Patients With Local Breast Cancer Control on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment

  5 years

• Number of Subjects With Fibrosis Defined Per Grades According to LENT/SOMA Fibrosis Scoring System on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment

  2-3 years

• Number of Subjects Reporting Breast Cosmesis According to BCTOS Questionnaire on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment

  2-3 years

• Number of Subjects With Fibrosis Defined Per Grades According to LENT/SOMA Fibrosis Scoring System on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment

  5 years

Study Arms (2)

ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions

EXPERIMENTAL

Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions

Radiation: Radiation therapy - 3 weeks

ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions

EXPERIMENTAL

Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions.

Radiation: Radiation therapy - 2 weeks

Interventions

Radiation therapy - 2 weeks RADIATION

Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions.

ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions

Radiation therapy - 3 weeks RADIATION

Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions

ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous radiation therapy to the ipsilateral breast.
• days from last surgery, unless s/p adjuvant chemotherapy
• days from last chemotherapy
• Male breast cancer

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (3)

New York Presbyterian Hospital at Lower Manhattan Cancer Center

New York, New York, 10007, United States

Location

Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, 11215, United States

Location

New York Presbyterian Hospital - Queens

New York, New York, 11355, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Fabiana Gregucci
• Organization: Weill Cornell Medicine

fgr4002@med.cornell.edu

6469623110

Study Officials

• Silvia Formenti, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: November 21, 2019
• Primary Completion: July 15, 2025
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)