Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
• Unifocal Disease
• Candidate for breast-conserving surgery
• Recommended treatment by multidisciplinary team
Locations
United States
California
John Wayne Cancer Institute, Providence Saint John's Health Center
RECRUITING
Santa Monica
Contact Information
Primary
Janie Grumley, MD
janie.grumley@providence.org
(310) 582-7100
Time Frame
Start Date: 2018-10-03
Estimated Completion Date: 2028-10-03
Participants
Target number of participants: 1000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Saint John's Cancer Institute