ACTIVE_NOT_RECRUITING

Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2019-11-21
Study Completion:2030-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04175210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 90 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women status post segmental mastectomy
  2. * If unilateral, pT1-2 breast cancer excised with negative margins
  3. * If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
  4. * Clinically N0 or pN0 or sentinel node negative
  5. * Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
  6. * Women with previous contralateral breast cancer.
  1. * Previous radiation therapy to the ipsilateral breast.
  2. * 90 days from last surgery, unless s/p adjuvant chemotherapy
  3. * 60 days from last chemotherapy
  4. * Male breast cancer

Contacts and Locations

Principal Investigator

Silvia Formenti, M.D.
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

New York Presbyterian Hospital at Lower Manhattan Cancer Center
New York, New York, 10007
United States
Brooklyn Methodist Hospital - NewYork Presbyterian
New York, New York, 11215
United States
New York Presbyterian Hospital - Queens
New York, New York, 11355
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Silvia Formenti, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-21
Study Completion Date2030-06-30

Study Record Updates

Study Start Date2019-11-21
Study Completion Date2030-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer