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Radiation
Ultrahypofractionation Radiation Therapy for Breast Cancer
N/A
Recruiting
Led By Rachel Jimenez, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 13 months (pre-treatment period to 12 month follow up)
Awards & highlights
Study Summary
This trial looks at how PBT may reduce cardiac changes in breast cancer patients compared to XRT.
Who is the study for?
This trial is for adults over 18 with non-metastatic left-sided breast cancer needing radiation, including internal mammary lymph nodes treatment. It's also open to right-sided or unfavorable cardiac anatomy cases as determined by the study lead. Pregnant/breastfeeding individuals, those with conditions like scleroderma or chronic kidney disease, and patients on other investigational studies evaluating cardiac toxicity are excluded.Check my eligibility
What is being tested?
The study compares two types of radiation therapy for breast cancer: Proton Beam Radiation Therapy (PBT) and Conventional Photon Radiation Therapy (XRT). The goal is to see if PBT causes fewer heart changes than XRT in patients with left-sided breast cancer, using MRI imaging for assessment.See study design
What are the potential side effects?
Potential side effects include skin reactions at the treatment site, fatigue, swelling in treated areas, and possible heart changes detectable by MRI. Both PBT and XRT may have unique impacts on heart health which this trial aims to investigate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 13 months (pre-treatment period to 12 month follow up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 months (pre-treatment period to 12 month follow up)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Myocardial Fibrosis from Baseline in Proton Beam Radiation Therapy (PBT)
Secondary outcome measures
Body Image Evaluation
Change in Global Longitudinal Strain (GLS) on CMR from Baseline
Change in Shoulder Function from Baseline
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Accelerated Proton Beam Radiation Therapy (PBT) GroupExperimental Treatment1 Intervention
Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:
Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.
Radiation therapy 1x daily for 5 days over 1 week.
End of radiation therapy visit with blood tests.
6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.
12 month follow up visit with questionnaires and photographic imaging.
Group II: Accelerated Photon Radiation Therapy (XRT) GroupExperimental Treatment1 Intervention
Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:
Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.
Radiation therapy 1x daily for 5 days over 1 week.
End of radiation therapy visit with blood tests.
6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.
12 month follow up visit with questionnaires and photographic imaging.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
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13,198,581 Total Patients Enrolled
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National Cancer Institute (NCI)NIH
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40,926,381 Total Patients Enrolled
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1,543,300 Patients Enrolled for Breast Cancer
American Society of Clinical OncologyOTHER
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147,993 Total Patients Enrolled
7 Trials studying Breast Cancer
910 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have gadolinium contrast due to a health condition like kidney disease.I cannot receive radiotherapy due to certain health conditions.I have had chemotherapy before.I have right-sided breast cancer or left-sided with specific heart concerns as determined by the study lead.I have breast cancer that has not spread and will receive radiation therapy to the left side or both sides, including the internal mammary lymph nodes.You do not have any reasons that would make it unsafe for you to have an MRI scan.I am 18 years old or older.I am not in a study for heart side effects and not on cancer-killing drugs or radiation now.
Research Study Groups:
This trial has the following groups:- Group 1: Accelerated Photon Radiation Therapy (XRT) Group
- Group 2: Accelerated Proton Beam Radiation Therapy (PBT) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still availability for enrolment in this clinical experiment?
"Despite being posted to clinicaltrials.gov on October 1st 2023, the recruitment phase for this trial has finished; however, there are over 3000 ongoing medical studies that welcome new participants."
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