Prospective Randomized Study of Accelerated Radiation Therapy (PRART) (PRART)

Prospective Randomized Study of Accelerated Radiation Therapy (PRART) : A Non-Inferiority Trial to Compare Breast Cosmesis and Local Control After Concomitant Boost Breast Radiotherapy With Fifteen Fractions in Three Weeks (Arm 1, Standard) Versus Ten Fractions in Two Weeks (Arm 2, Experimental)

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Radiation therapy - 3 weeks; Radiation: Radiation therapy - 2 weeks

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pragya Yadav, Ph.D.; Phone Number: 6469622199; Email: pry2003@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 11215
      • Recruiting
      • Brooklyn Methodist Hospital - NewYork Presbyterian
      • Contact: Izael Nino; Email: izn4001@med.cornell.edu
      • Contact: Pragya Yadav, Ph.D.; Phone Number: 6469622199; Email: pry2003@med.cornell.edu
      • Principal Investigator: Hani Ashamalla, M.D.
    • New York, New York, United States, 11355
      • Recruiting
      • New York Presbyterian Hospital - Queens
      • Principal Investigator: Akkamma Ravi, M.D.
      • Contact: Pragya Yadav, Ph.D; Phone Number: 6469622199; Email: pry2003@med.cornell.edu
      • Contact: Pragya Khadka; Phone Number: 718-670-1541; Email: prk4003@med.cornell.edu
    • New York, New York, United States, 10007
      • Recruiting
      • New York Presbyterian Hospital at Lower Manhattan Cancer Center
      • Principal Investigator: Silvia Formenti, M.D.
      • Contact: Pragya Yadav, Ph.D.; Phone Number: 646-962-2199; Email: pry2003@med.cornell.edu
      • Contact: Sharanya Chandrasekhar, M.S.; Phone Number: 646-962-3110; Email: shc2043@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions; 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; 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
Experimental: ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events receiving radiation therapy between the two arms Arm 1 (15 fractions) and Arm 2 (10 fractions).	rate of grade 3 or higher changes in breast cosmesis on the 10 fraction arm compared to the rate on the 15 fraction arm will be measured.	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who demonstrate local control at 5 year follow up	assess and compare local control at 5 years between the two arms.	5 years

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Silvia Formenti, M.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-07020533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes