- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04603209
Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer
Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
At Providence Saint John's Health Center, there is the ongoing integration of Intra-Operative Radiation Therapy (IORT) as a standard treatment option among Breast Conserving Therapy (BCT) for individuals with in situ and early stage breast cancer. Currently, approximately 60 women per year are being treated with IORT. No repository of information of patient outcomes with this treatment has been established. This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT.
As the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint John's Health Center, this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy. In addition, the Providence Health & Services strives to improve patient care and outcomes with excellence whenever possible. The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Janie Grumley, MD
- Phone Number: (310) 582-7100
- Email: janie.grumley@providence.org
Study Locations
-
-
California
-
Santa Monica, California, United States, 90404
- Recruiting
- John Wayne Cancer Institute, Providence Saint John's Health Center
-
Contact:
- Janie Grumley, MD
- Phone Number: 310-582-7100
- Email: janie.grumley@providence.org
-
Sub-Investigator:
- Robert Wollman, MD
-
Sub-Investigator:
- Lisa Chaiken, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
- Unifocal Disease
- Candidate for breast-conserving surgery
- Recommended treatment by multidisciplinary team
Exclusion Criteria:
- Clinical stage T3-4, N1-3, M1
- Multifocal disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IORT
All participants who plan to undergo partial mastectomy for treatment of early stage breast cancer will be considered for eligibility for IORT.
Patient with single breast cancer less than 3cm in disease span, clinical negative axillary node will be offered the option of having IORT.
If IORT is delivered following surgical resection of the tumor they will be followed in this registry for short and long term outcomes.
|
IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Recurrence
Time Frame: 5 years
|
Presence of recurrent tumor in ipsilateral breast or distant site
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease specific survival
Time Frame: 10 years
|
survival
|
10 years
|
Overall Survival
Time Frame: 10 years
|
survival
|
10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Janie Grumley, MD, John Wayne Cancer Institute, Providence Saint John's Health Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY2019000317
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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