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Brachytherapy
IORT + CT-Guided Brachytherapy for Breast Cancer
N/A
Waitlist Available
Led By Shayna Showalter
Research Sponsored by Shayna Showalter, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer.
Patient is 45 years of age or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months after treatment
Awards & highlights
Study Summary
This trial is testing a new way to give radiation therapy to people with early-stage breast cancer.
Who is the study for?
This trial is for women over 45 with early-stage breast cancer where the tumor is no larger than 3 cm. They must be planning surgery to conserve their breast or remove the whole breast. It's not for those with spread to lymph nodes, prior treatment to shrink the tumor, men, pregnant women, those with implants before radiotherapy, multiple tumors in one breast, skin/chest wall-involved cancer, previous same-side breast cancer or known BRCA mutation.Check my eligibility
What is being tested?
The study tests a new method of delivering radiation therapy called IORT with CT-Guided HDR Brachytherapy during surgery for early-stage breast cancer. The goal is to see if this approach effectively treats cancer at the time of operation.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with radiation therapy such as localized pain, swelling or redness; changes in skin texture; and fatigue. There might also be specific complications related to brachytherapy like infection or tissue damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I chose a lumpectomy or radiation for my early-stage breast cancer.
Select...
I am 45 years old or older.
Select...
My tumor is 3 cm or smaller.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Local Breast Tumor Recurrence
Secondary outcome measures
Cancer Specific-Survival and Overall Survival Response Rate
Changes in Patient-Reported Quality of Life
Changes in Reported Patient and Physician Cosmetic Descriptions
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: IORT with CT-Guided HDR BrachytherapyExperimental Treatment1 Intervention
Patients will receive IORT with CT-guided HDR brachytherapy at the time of breast surgery.
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Who is running the clinical trial?
Shayna Showalter, MDLead Sponsor
2 Previous Clinical Trials
111 Total Patients Enrolled
1 Trials studying Breast Cancer
28 Patients Enrolled for Breast Cancer
Shayna ShowalterPrincipal Investigator - University of Virginia
University of Virginia Medical Center
University Of Virginia School Of Medicine (Medical School)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have multiple cancer sites in the same breast.I have a known BRCA gene mutation.I am starting treatment to shrink my tumor.I chose a lumpectomy or radiation for my early-stage breast cancer.My cancer has spread to my lymph nodes.My breast cancer has spread to my skin or chest wall.I have had breast cancer in the same breast before.I am 45 years old or older.My tumor is 3 cm or smaller.I am a male.
Research Study Groups:
This trial has the following groups:- Group 1: IORT with CT-Guided HDR Brachytherapy
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.
Are there currently any vacancies for participants in this clinical trial?
"Clinicaltrials.gov confirms that this clinical trial is actively seeking participants; it was initially published on March 1, 2015 and has been updated in July 18th of 2019."
Answered by AI
How many participants are affiliated with this research endeavor?
"This trial necessitates the enrollment of 358 patients that meet specific inclusion criteria. Participants can travel to either University of Virginia in Charlottesville, Virginia or Hackensack Meridian Health - John Theurer Cancer Center in Hackensack, New jersey to take part."
Answered by AI
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