NCT05289466

Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.

Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Saint John's Cancer Institute · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.

Conditions

• IORT-Intra-Operative Radiation Therapy

Interventions

Type	Name	Description
RADIATION	Intraoperative Radiotherapy	Intraoperative Radiotherapy (Xoft, 20 Gy single dose)
PROCEDURE	Oncoplastic partial mastectomy	Breast Conserving Therapy

Timeline

• Start date: 2021-12-16
• Primary completion: 2024-10-23
• Completion: 2024-10-23
• First posted: 2022-03-21
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study