Prospective Randomized Study of Accelerated Radiation Therapy (PRART)
NCT ID: NCT04175210
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2019-11-21
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 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
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 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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 90 days from last surgery, unless s/p adjuvant chemotherapy
* 60 days from last chemotherapy
* Male breast cancer
19 Years
90 Years
FEMALE
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Silvia Formenti, M.D.
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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New York Presbyterian Hospital at Lower Manhattan Cancer Center
New York, New York, United States
Brooklyn Methodist Hospital - NewYork Presbyterian
New York, New York, United States
New York Presbyterian Hospital - Queens
New York, New York, United States
Countries
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Other Identifiers
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19-07020533
Identifier Type: -
Identifier Source: org_study_id
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