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NCT04175210 | RECRUITING | Breast Cancer

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

Weill Medical College of Cornell University

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

Breast Cancer

Intervention/treatment

Radiation therapy - 3 weeks

Radiation therapy - 2 weeks

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : NONE
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 : 2019-11-21
Estimated Primary Completion Date : 2027-02-28
Estimated Study Completion Date : 2030-02-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years to 90 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Location Details

NCT04175210

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

New York Presbyterian Hospital at Lower Manhattan Cancer Center

New York, New York, United States, 10007

RECRUITING

United States, New York

Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, United States, 11215

RECRUITING

United States, New York

New York Presbyterian Hospital - Queens

New York, New York, United States, 11355