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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04603209
Enrollment
1000
Registered
2020-10-26
Start date
2018-10-03
Completion date
2028-10-03
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-stage Breast Cancer, Breast Carcinoma in Situ, Breast Neoplasms

Keywords

Breast Cancer, Early-stage Breast Cancer, Intraoperative Radiotherapy, IORT

Brief summary

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

IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery

Sponsors

Saint John's Cancer Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disease Recurrence5 yearsPresence of recurrent tumor in ipsilateral breast or distant site

Secondary

MeasureTime frameDescription
Disease specific survival10 yearssurvival
Overall Survival10 yearssurvival

Countries

United States

Contacts

Primary ContactJanie Grumley, MD
janie.grumley@providence.org(310) 582-7100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026