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Radiation Therapy

Accelerated Radiation Therapy for Breast Cancer (PRART Trial)

Phase 3
Recruiting
Led By Silvia Formenti, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women status post segmental mastectomy
If unilateral, pT1-2 breast cancer excised with negative margins
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

PRART Trial Summary

This trial is testing whether a shorter, more intensive course of radiation therapy is as effective as the standard course of treatment for early stage breast cancer.

Who is the study for?
This trial is for women who've had a specific breast surgery for early-stage cancer (Stage 0, T1-T2) with no cancer left at the edges of removed tissue and no spread to lymph nodes. It's not open to men, those treated within 60 days after chemotherapy or 90 days post-surgery if they received chemo, or anyone previously radiated on the same breast.Check my eligibility
What is being tested?
The study compares two schedules of radiation therapy after breast surgery: one group receives standard treatment over three weeks while another gets an experimental shorter course over two weeks. Both groups also get extra radiation focused on where the tumor was.See study design
What are the potential side effects?
Radiation may cause skin irritation, fatigue, swelling in the treated breast, changes in skin color or texture, and rarely more serious effects like heart problems or secondary cancers.

PRART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a segment of my breast surgically removed.
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My breast cancer was removed with clear margins.
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My breast cancer is contained and hasn't spread beyond its original site.
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My cancer has not spread to nearby lymph nodes.

PRART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with adverse events receiving radiation therapy between the two arms Arm 1 (15 fractions) and Arm 2 (10 fractions).
Secondary outcome measures
Number of participants who demonstrate local control at 5 year follow up

PRART Trial Design

2Treatment groups
Experimental Treatment
Group I: ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractionsExperimental Treatment1 Intervention
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.
Group II: ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractionsExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,315,909 Total Patients Enrolled
29 Trials studying Breast Cancer
26,816 Patients Enrolled for Breast Cancer
Silvia Formenti, M.D.Principal InvestigatorWeill Medical College of Cornell University
13 Previous Clinical Trials
919 Total Patients Enrolled
6 Trials studying Breast Cancer
742 Patients Enrolled for Breast Cancer

Media Library

Radiation therapy - 3 weeks (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04175210 — Phase 3
Breast Cancer Research Study Groups: ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions, ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions
Breast Cancer Clinical Trial 2023: Radiation therapy - 3 weeks Highlights & Side Effects. Trial Name: NCT04175210 — Phase 3
Radiation therapy - 3 weeks (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04175210 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly citizens able to participate in this research?

"As this study is only open to adults, the age range for applicants is between 19 and 90. Out of the 2135 total clinical trials, 53 are geared towards minors while 1379 focus on senior citizens."

Answered by AI

What is the maximum number of people who can participate in this research project?

"Yes, that is correct. The clinical trial is still recruiting patients and was originally posted on November 21st, 2019. The most recent update to the posting was on July 29th, 2022. They are looking for 400 people to participate at 3 different sites."

Answered by AI

Are there any requirements to participate in this clinical trial?

"Women who have been diagnosed with breast cancer and are aged between 19-90 may be eligible for this study. There is a goal to enroll 400 patients in total."

Answered by AI

Are individuals with the required health criteria able to enroll in this research project at this time?

"Yes, the clinicaltrials.gov website currently lists this study as open and recruiting patients. This research trial was first made public on 21st November 2019 with the most recent update being 29th July 2022. The team conducting the study are looking for 400 individuals from 3 different hospitals or clinics."

Answered by AI

How does Radiation therapy - 3 weeks affect patients?

"There is some data affirming the efficacy of this radiation therapy, as well as evidence from multiple rounds of testing that suggest it is a safe treatment option."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Virginia
Other
California
What site did they apply to?
Brooklyn Methodist Hospital - NewYork Presbyterian
New York Presbyterian Hospital at Lower Manhattan Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Prospective Randomized Study of Accelerated Radiation Therapy (PRART)
2019. "Prospective Randomized Study of Accelerated Radiation Therapy (PRART)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04175210.
~52 spots leftby Dec 2024
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