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Radiation Therapy

High vs Standard Dose Radiation Therapy for Breast Cancer

Phase 3
Waitlist Available
Led By Frank A. Vicini, MD, FACR
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole breast irradiation with boost without regional nodal irradiation planned
Age ≥ 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is studying two different radiation therapy regimens to see how well they work in treating patients with early-stage breast cancer.

Who is the study for?
This trial is for women over 18 who've had early-stage breast cancer surgically removed within the last 50 days. They must not be pregnant, agree to use contraception during treatment, and have no history of certain cancers or severe illnesses. Breast implants are okay, but prior radiation therapy in the same area or plans for chemotherapy alongside this treatment disqualify them.Check my eligibility
What is being tested?
The study compares two types of radiation therapy after breast surgery: a higher dose given less frequently with a concurrent boost versus the standard daily dose with a sequential boost. It's randomized, meaning patients are put into groups by chance to see which method works best.See study design
What are the potential side effects?
Radiation therapy can cause skin irritation at the site of treatment, fatigue, swelling in the treated breast (lymphedema), changes in breast size and shape, and rarely more serious complications like heart problems or secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had surgery to remove breast cancer and radiation on the whole breast without treating the lymph nodes.
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I am 18 years old or older.
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I am not pregnant or breastfeeding and agree to use birth control during radiation therapy.
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I am within 50 days of my last breast surgery or chemotherapy.
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I am female.
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My multifocal breast cancer was removed in one surgery with clear margins.
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I had a CT scan of the affected breast within the last 28 days for radiation planning.
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I have taken a pregnancy test in the last 14 days and it was negative.
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My cancer has not spread to distant parts of my body.
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My breast surgery removed all visible cancer with clear edges.
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My recent blood test shows my bone marrow is working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Percentage of Participants With In-breast Recurrence (Local Failure)
Secondary outcome measures
Change in Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis Subscale Score From Baseline to 3 Years
Correlation Between Dose-volume Data and Both Adverse Events and Efficacy
Number of Participants by Highest Grade Adverse Event Reported as Definitely, Probably, or Possibly Related to Protocol Treatment
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hypofractionated whole breast irradiation + concurrent boostExperimental Treatment2 Interventions
Hypofractionated whole breast (H-WBI) irradiation with a concurrent boost
Group II: Whole breast irradiation + sequential boostActive Control2 Interventions
Standard fractionation whole breast irradiation (WBI) with sequential boost.

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER
231 Previous Clinical Trials
98,470 Total Patients Enrolled
8 Trials studying Breast Cancer
9,284 Patients Enrolled for Breast Cancer
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
62,573 Total Patients Enrolled
9 Trials studying Breast Cancer
8,057 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,910,921 Total Patients Enrolled
938 Trials studying Breast Cancer
1,540,979 Patients Enrolled for Breast Cancer

Media Library

Higher per daily radiation therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01349322 — Phase 3
Breast Cancer Research Study Groups: Whole breast irradiation + sequential boost, Hypofractionated whole breast irradiation + concurrent boost
Breast Cancer Clinical Trial 2023: Higher per daily radiation therapy Highlights & Side Effects. Trial Name: NCT01349322 — Phase 3
Higher per daily radiation therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01349322 — Phase 3

Frequently Asked Questions

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

Are there any health risks associated with Whole breast irradiation delivered by 3-dimensional conformal radiation therapy or intensity modulated radiation therapy?

"Given that this is a Phase 3 trial with efficacy data and multiple rounds of safety testing, our team at Power has rated Whole breast irradiation delivered by 3-dimensional conformal radiation therapy or intensity modulated radiation therapy as having a level of safety at a 3."

Answered by AI

Are investigators looking for more test subjects at this time?

"Unfortunately, this study is not taking on any more patients at the moment. However, according to clinicaltrials.gov, which has updated information from as recent as April 6th, 2022, there are 2695 other trials that might be a good match for you."

Answered by AI

In how many different areas is this study being conducted?

"At the moment, this clinical trial is enrolling patients at 100 sites. The locations are situated in Akron, East Stroudsburg and Cincinnati along with other locations 100 other locations. If you participate, it would be most convenient to select a location closest to you to minimize travel requirements."

Answered by AI
~170 spots leftby Mar 2025