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

NCT ID: NCT04603209

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-03
• Study Completion Date: 2028-10-03

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Intraoperative Radiation Therapy (IORT)

Intervention Type: RADIATION

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

Interventions

Intraoperative Radiation Therapy (IORT)

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint John's Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Janie Grumley

Director of the Comprehensive Breast Program, Margie Petersen Breast Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janie Grumley, MD

Role: PRINCIPAL_INVESTIGATOR

John Wayne Cancer Institute, Providence Saint John's Health Center

Locations

John Wayne Cancer Institute, Providence Saint John's Health Center

Santa Monica, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Janie Grumley, MD

Role: CONTACT

janie.grumley@providence.org

(310) 582-7100

Facility Contacts

Janie Grumley, MD

Role: primary

janie.grumley@providence.org

310-582-7100

Other Identifiers

STUDY2019000317

Identifier Type: -

Identifier Source: org_study_id