- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266602
Intraoperative Radiation Therapy in Early Stage Breast Cancer (IORTBreast)
April 24, 2019 updated by: Michelle Yao, Benaroya Research Institute
Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer
Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of:
- Local recurrence in early stage breast cancer patients treated with IORT.
- Toxicity associated with IORT.
- Long-term disease-specific and overall survival
- Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.
- Quality of life in patients treated with IORT.
- Health care costs associated with IORT.
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
General Inclusion Criteria
- Age ≥ 45 years.
- Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).
- Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.
Exclusion Criteria:
- Scleroderma, systemic sclerosis and active lupus.
- Participation in an investigational drug or device study.
- Previous ipsilateral radiation to the thorax or breast.
- Multifocal breast cancer.
- Pregnant patients.
- Patient not competent to provide informed consent.
- Neoadjuvant systemic therapy.
- Lymphovascular invasion on biopsy pathology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Treatment
Patients treated with intraoperative radiation therapy at the time of partial mastectomy.
|
Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local Disease Relapse
Time Frame: 10 years
|
Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence.
In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease.
Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease specific and overall survival
Time Frame: 10 years
|
Disease specific and overall survival will be obtained for all patients in the study.
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Janie Grumley, MD, Virginia Mason Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (ACTUAL)
July 30, 2018
Study Completion (ACTUAL)
July 31, 2018
Study Registration Dates
First Submitted
October 10, 2014
First Submitted That Met QC Criteria
October 14, 2014
First Posted (ESTIMATE)
October 17, 2014
Study Record Updates
Last Update Posted (ACTUAL)
April 26, 2019
Last Update Submitted That Met QC Criteria
April 24, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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