Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative Radiation Therapy (IORT).
- Who it may be relevant to
- Registry conditions: Early-stage Breast Cancer, Breast Carcinoma in Situ, Breast Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer
Overview
This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.
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.
Interventions
- Radiation Intraoperative Radiation Therapy (IORT)
IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery
Primary outcome measures
- Disease Recurrence [Time frame: 5 years]
Secondary outcome measures (2)
- Disease specific survival [Time frame: 10 years]
- Overall Survival [Time frame: 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- John Wayne Cancer Institute, Providence Saint John's Health Center — Santa Monica
Identifiers
NCT: NCT04603209 · STUDY2019000317