Registry for Intra-Operative Radiotherapy in 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
Saint John's Cancer Institute · NCT04603209
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint John's Cancer Institute (other) |
| Drugs / interventions | Radiation |
| Locations | 1 site (Santa Monica, California) |
| Trial ID | NCT04603209 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with advanced clinical stages (T3-4, N1-3, M1) or multifocal disease may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Santa Monica, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Early-stage Breast Cancer, Breast Carcinoma in Situ, Breast Neoplasms, Breast Cancer, Intraoperative Radiotherapy, IORT