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Pre-Surgery Radiation Boost for Breast Cancer
N/A
Recruiting
Led By Bruce G Haffty
Research Sponsored by Rutgers, The State University of New Jersey
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 measured 1-5 weeks prior to surgery and measured 1-7 weeks after surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether delivering a part of the radiation treatment before surgery, when doctors can still visualize the tumor, may help to better target the tumor and decrease the volume of normal irradiated tissue.
Who is the study for?
This trial is for individuals with non-metastatic breast cancer, who are in good physical condition (ECOG 0-1), and have no signs of cancer spread. Pregnant women must test negative for pregnancy. Participants should be willing to follow the study protocol and haven't had prior chest radiation or chemotherapy.
What is being tested?
The trial studies the safety of a 'boost' dose of radiation given before surgery to target tumors more precisely, potentially improving cosmetic outcomes and tumor control. It includes quality-of-life assessments and MRI scans as part of evaluating this approach.
What are the potential side effects?
Potential side effects may include skin changes, fatigue, discomfort at the treatment site, swelling or scar tissue formation in the treated breast area. The boost aims to minimize normal tissue exposure but individual reactions can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured 1-5 weeks prior to surgery and measured 1-7 weeks after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured 1-5 weeks prior to surgery and measured 1-7 weeks after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.
Secondary study objectives
Physician reported cosmesis
Other study objectives
Acute and late radiation toxicity
Clinical target volume (CTV)
Patient reported cosmesis
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy boost, WBI)Experimental Treatment6 Interventions
Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Whole Breast Irradiation
2017
N/A
~160
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
449 Previous Clinical Trials
65,750 Total Patients Enrolled
15 Trials studying Breast Cancer
1,000 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,946 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,237 Patients Enrolled for Breast Cancer
Bruce G HafftyPrincipal InvestigatorRutgers Cancer Institute of New Jersey
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You require chemotherapy before surgery.You have received radiation therapy on the same side of your body as the breast or chest area.You have inflammatory breast cancer at an advanced stage.You can participate if you have cancer in both sides of your body at the same time.You are able to perform daily activities and take care of yourself with little to no assistance.You must have a negative pregnancy test within one month before receiving radiation therapy.You have breast cancer confirmed by a biopsy.You cannot have a baseline MRI for medical reasons.You do not have any visible signs of cancer in your lymph nodes during a physical exam or on imaging tests.You have multiple tumors in different places in your body.Cancer has spread to other parts of the body.You have another type of cancer at the same time, except for cancer in both breasts.You have a condition that makes receiving radiation therapy unsafe, like scleroderma or another collagen vascular disease.You do not have cancer that has spread to other parts of your body.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (radiation therapy boost, WBI)
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.
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