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ACTIVE NOT RECRUITING
NCT02755896
PHASE2

Trial to Compare Radiation Fibrosis With Five Versus Three Fractions

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the completion of treatment then q6 months for the first year, then yearly for the next 10 years.

Official title: Prone Partial Breast Irradiation (PBI): Prospective Randomized Controlled Non-inferiority Trial to Compare Radiation Fibrosis With Five Versus Three Fractions

Key Details

Gender

FEMALE

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2015-10-14

Completion Date

2027-12

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

RADIATION

Arm 1 600 cGY x 5 fractions

Patients who are randomized to Arm 1 will receive either 600 cGY x 5 fractions over 5 consecutive days

RADIATION

Arm 2 800 cGY x 3 fractions

Patients who are randomized to Arm 2 will receive 800 cGY x 3 fractions given every other day

Locations (4)

University of Southern California

Los Angeles, California, United States

Weill Cornell Medical College

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