RECRUITING

Two Versus One Week Breast Radiotherapy (RT)

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Conditions

Breast CancerAccelerated RadiotherapyProne PositionAdjuvant SettingNon-InferiorityConcomitant Boost

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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

This study is comparing two different radiation therapy approaches for early breast cancer to see which one is better for patients. One group will receive radiation over one week (based on the FAST-FORWARD trial), and the other group will receive radiation over two weeks with an extra focused dose (called a "concomitant boost"). The study will look at how the treatments affect side effects, breast appearance, and cancer control in the breast. It also aims to find out if the two-week treatment does a better job at preventing cancer from coming back in the breast over the long term.

Official Title

Prospective Randomized Trial of Two Versus One Week Accelerated Radiotherapy (PRATO)

Quick Facts

Study Start:2025-04-29
Study Completion:2040-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06960707

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:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Women status post segmental mastectomy.
  2. 2. If unilateral, pT1-2 breast cancer excised with negative margins.
  3. 3. If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
  4. 4. Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx or sentinel node negative.
  5. 5. Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
  6. 6. Women with previous contralateral treated breast cancer can be enrolled in the trial.
  1. 1. Previous radiation therapy to the ipsilateral breast.
  2. 2. \>90 days from last surgery, unless s/p adjuvant chemotherapy.
  3. 3. \>60 days from last chemotherapy.
  4. 4. Male breast cancer.
  5. 5. Ongoing treatment for severe autoimmune disease.

Contacts and Locations

Study Contact

Fabiana Gregucci, MD
CONTACT
6469623110
fgr4002@med.cornell.edu
Fereshteh Talebi, MD
CONTACT
6467027830
fet4007@med.cornell.edu

Principal Investigator

Silvia C. Formenti, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Brooklyn Methodist Hospital
New York, New York, 11215
United States
New York Presbyterian Hospital
New York, New York, 11355
United States
New York-Presbyterian Weill Cornell Medical College
New York, New York, 11355
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Silvia C. Formenti, MD, 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 Date2025-04-29
Study Completion Date2040-12-31

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2040-12-31

Terms related to this study

Keywords Provided by Researchers

  • Accelerated Radiotherapy
  • Prone Position
  • Adjuvant Setting
  • Non-Inferiority
  • Concomitant Boost

Additional Relevant MeSH Terms

  • Breast Cancer