Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer

Recruiting

• Conditions: Early-stage Breast Cancer; Breast Carcinoma in Situ; Breast Neoplasms
• Interventions: Radiation: Intraoperative Radiation Therapy (IORT)

• Registration Number: NCT04603209
• Lead Sponsor: Saint John's Cancer Institute

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.

Study Timeline

• Study Start: 2018-10-03
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2028-10-03
• Study Completion: 2028-10-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IORT	Intraoperative Radiation Therapy (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.

Primary Outcome Measures

Name	Time	Method
Disease Recurrence	5 years	Presence of recurrent tumor in ipsilateral breast or distant site

Secondary Outcome Measures

Name	Time	Method
Disease specific survival	10 years	survival
Overall Survival	10 years	survival

Trial Locations

Locations (1)

John Wayne Cancer Institute, Providence Saint John's Health Center; 🇺🇸 Santa Monica, California, United States