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Brachytherapy
Intraoperative Radiation Therapy for Breast Cancer
N/A
Recruiting
Led By Michael Alvarado, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Suitable for breast conserving surgery
T1 and T2 (< 3.5 cm), N0, M0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new way to give radiation therapy for breast cancer that may be as effective as the standard way, and has fewer side effects.
Who is the study for?
This trial is for individuals with early stage breast cancer (T1 and T2, no larger than 3.5 cm, no spread to lymph nodes or other parts of the body) who are suitable for breast-conserving surgery. It's not open to those under 50, with tumors over 3 cm, estrogen receptor negative cancers, HER2 positive status, high-grade tumors or extensive intraductal component.Check my eligibility
What is being tested?
The study is testing intraoperative radiation therapy given one time during surgery where the tumor was removed. The goal is to see if this method can effectively kill any remaining tumor cells and compare its effectiveness against standard radiation treatments in patients with early-stage breast cancer.See study design
What are the potential side effects?
While specific side effects aren't listed here, intraoperative radiation therapy could potentially cause skin irritation at the treatment site, fatigue similar to traditional radiation therapy effects and may have risks associated with surgical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a candidate for surgery that will not remove my entire breast.
Select...
My cancer is small (under 3.5 cm) and has not spread to lymph nodes or other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of site of relapse within the breast
Incidence of local recurrence
Median Overall Survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (IORT)Experimental Treatment2 Interventions
Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intraoperative Radiation Therapy
2012
N/A
~500
Find a Location
Who is running the clinical trial?
Carl Zeiss Meditec AGIndustry Sponsor
41 Previous Clinical Trials
6,454 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,236,055 Total Patients Enrolled
46 Trials studying Breast Cancer
3,828,435 Patients Enrolled for Breast Cancer
Michael Alvarado, MDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Unable to determine if the edges of the tissue removed during surgery are clear of cancer.I was diagnosed with cancer in both breasts at the same time.My breast cancer has spread to the lymph nodes under my arm.I have a known BRCA1 or BRCA2 gene mutation.I am receiving initial treatment to shrink my tumor before surgery.My cancer is HER2 positive.My tumor is larger than 3 cm.My cancer has spread to my lymph nodes.I have had chemotherapy or hormone therapy before.My cancer is not driven by estrogen.I am a candidate for surgery that will not remove my entire breast.My cancer is small (under 3.5 cm) and has not spread to lymph nodes or other parts of my body.I am under 50 years old.My condition is considered high grade.My same breast had cancer before or received radiation.I have multiple cancer areas in one breast, not removable by one surgery.My breast cancer surgery showed more than 25% of the tissue had non-invasive cancer.Presence of lymphovascular invasion.My tumor is larger than 3.5 cm.I had cancer before but my doctor expects me to be cancer-free for the next 10 years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (IORT)
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 currently an opportunity for subjects to join this research effort?
"Affirmative. As verified on clinicaltrials.gov, this trial is actively enrolling and was initially posted on May 18th 2012. 1500 participants are needed to be recruited from 12 different sites in total."
Answered by AI
What is the count of participants admitted to this trial?
"Carl Zeiss Meditec AG, the sponsor of this research project, is looking to enrol 1500 participants who meet the trial's criteria. These patients will be recruited at Marie Yeager Cancer Center, Spectrum Health Lakeland in Saint Joseph, Michigan and Mercy Medical Center in Baltimore, Maryland."
Answered by AI
How many sites have been selected to administer this clinical trial?
"This experimental drug is being tested at 12 different medical centres, including Marie Yeager Cancer Center, Spectrum Health Lakeland in Saint Joseph, Mercy Medical Center in Baltimore and Columbia University/Herbert Irving Cancer Centre in New york."
Answered by AI
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