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ACTIVE NOT RECRUITING
NCT04175210
PHASE3

Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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).

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)

Key Details

Gender

FEMALE

Age Range

19 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2019-11-21

Completion Date

2030-06-30

Last Updated

2025-07-25

Healthy Volunteers

No

Conditions

Interventions

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

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.

Locations (3)

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