We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175210
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Radiation therapy - 3 weeks Radiation: Radiation therapy - 2 weeks Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of patients with adverse events receiving radiation therapy between the two arms Arm 1 (15 fractions) and Arm 2 (10 fractions). [ Time Frame: up to 5 years ]
    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.


Secondary Outcome Measures :
  1. Number of participants who demonstrate local control at 5 year follow up [ Time Frame: 5 years ]
    assess and compare local control at 5 years between the two arms.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175210


Contacts
Layout table for location contacts
Contact: Charles Ekeh, M.D. 6469622196 che4005@med.cornell.edu
Contact: Pragya Yadav, Ph.D. 6469622199 pry2003@med.cornell.edu

Locations
Layout table for location information
United States, New York
New York Presbyterian Hospital at Lower Manhattan Cancer Center Recruiting
New York, New York, United States, 10007
Contact: Charles Ekeh, M.D.    646-962-2196    shc2043@med.cornell.edu   
Contact: Pragya Yadav, Ph.D.    6469622199    pry2003@med.cornell.edu   
Principal Investigator: Silvia Formenti, M.D.         
Brooklyn Methodist Hospital - NewYork Presbyterian Recruiting
New York, New York, United States, 11215
Contact: Izael Nino       izn4001@med.cornell.edu   
Contact: Pragya Yadav, Ph.D.    6469622199    pry2003@med.cornell.edu   
Principal Investigator: Hani Ashamalla, M.D.         
New York Presbyterian Hospital - Queens Recruiting
New York, New York, United States, 11355
Contact: Sarah Stankiewich, B.S.    718-661-7246    sas9306@nyp.org   
Contact: Pragya Yadav, Ph.D    6469622199    pry2003@med.cornell.edu   
Principal Investigator: Akkamma Ravi, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Silvia Formenti, M.D. Weill Medical College of Cornell University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04175210    
Other Study ID Numbers: 19-07020533
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes