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Radiation Therapy
Radiation Therapy for Breast Cancer
N/A
Waitlist Available
Led By Sasha Beyer, MD, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial studies how radiation therapy affects the risk of shoulder or arm problems in breast cancer patients with lymph node involvement.
Who is the study for?
This trial is for women with lymph-node positive breast cancer who've had a lumpectomy or mastectomy, possibly followed by reconstruction. They should be within 84 days post-surgery or chemotherapy, not pregnant or breastfeeding, and willing to use contraception during the study. Excluded are those with non-epithelial breast cancers, prior chest radiation, shoulder surgery on the same side as the cancer, impaired shoulder mobility unrelated to cancer surgery, active lupus/scleroderma/dermatomyositis with rash.Check my eligibility
What is being tested?
The study compares two types of radiation therapy: Intensity Modulated Radiation Therapy (IMRT) and 3-Dimensional Conformal Radiation Therapy (3D-CRT). It aims to determine if IMRT results in less harm to the shoulder/arm area than 3D-CRT for patients with lymph-node positive breast cancer.See study design
What are the potential side effects?
Potential side effects include skin changes like redness and irritation at the treatment site, fatigue due to radiation exposure, possible temporary swelling of the treated breast area (lymphedema), joint stiffness or pain in the shoulder/arm region.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)
Secondary outcome measures
Body Weight Changes
Distant metastases in patients treated with IMRT
Dosimetric parameters associated with worse arm/shoulder morbidity as measured by the DASH
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (3DCRT)Experimental Treatment1 Intervention
Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.
Group II: Arm A (IMRT)Experimental Treatment1 Intervention
Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,380 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,034 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
Sasha Beyer, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a type of breast cancer that is not the common kind.You have had any type of breast cancer in the past, except for lobular carcinoma in situ (LCIS).You have been diagnosed with breast cancer through a pathology test.You have had surgery on the same side as the shoulder for any reason before.Your shoulder on the same side as the breast cancer surgery is already not moving well because of another health problem, as confirmed by your doctor.You have had radiation treatment on your breast or the area around it that would overlap with the study's radiation treatment.You have not had surgery to remove the disease in certain areas of your body.There is evidence that the cancer has spread to other parts of the body.You have active systemic lupus, erythematosus, scleroderma, or dermatomyositis with active rash.You have not received chemotherapy, anti-HER2 therapy, or endocrine therapy before the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (IMRT)
- Group 2: Arm B (3DCRT)
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.
Has recruitment begun for this research endeavor?
"Information available on clinicaltrials.gov reveals that this medical trial, which was first listed in September 2019 and last updated in April 2023, is not currently accepting new patients. Nevertheless, there are 2305 alternative studies that require participants at present."
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