Registry for Intra-Operative Radiotherapy in Early Stage Breast Cancer
Official title: Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer
Run by Saint John's Cancer Institute · NCT04603209 · Data updated 2026-11-12
This study is trying to see if a new type of radiation treatment given during breast surgery is safe and effective for women with early stage breast cancer compared to the usual radiation therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Saint John's Cancer Institute Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Santa Monica, California) |
| Status | Recruiting |
| Started | October 3, 2018 |
| Main results expected | October 3, 2028 |
| Study ends | October 3, 2028 |
| Registry record updated | April 16, 2024 |
| Trial ID | NCT04603209 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with clinical stage Tis, T1, or T2 (≤ 3cm), N0, M0 breast cancer who are suitable for breast-conserving surgery.
✕Probably not a fit
Patients with advanced clinical stages (T3-4, N1-3, M1) or multifocal disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective registry study enrolls women with early stage breast cancer undergoing intraoperative radiotherapy (IORT) during breast-conserving surgery. The aim is to validate the long-term effectiveness and safety of IORT by assessing patient outcomes, including complications, disease recurrences, and survival rates. The registry will compare these outcomes with traditional whole breast radiation therapy, filling a critical gap in existing data on IORT. This initiative is part of a broader effort to enhance breast cancer care at Providence Saint John's Health Center.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of IORT, potentially improving treatment options for early stage breast cancer patients.
How similar studies have gone: While the use of IORT is growing, this registry aims to establish a comprehensive database of outcomes, making it a novel approach in assessing this treatment method.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
John Wayne Cancer Institute, Providence Saint John's Health Center
Santa Monica, California, United States Recruiting
Study contacts
- Principal investigator: Janie Grumley, MD — John Wayne Cancer Institute, Providence Saint John's Health Center
- Study coordinator: Janie Grumley, MD
- Email: janie.grumley@providence.org
- Phone: (310) 582-7100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.