NCT01570998

Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery

Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,259 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To establish eligibility criteria based on previously published trials and studies in order to allow women who meet these criteria to receive intraoperative radiation therapy (IORT) on an Institutional Review Board (IRB)-approved protocol. II. To systematically collect and assess acute and long-term toxicity and outcomes in larger cohort of patients. III. To study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery, with or without whole breast radiation, as indicated by pathologic risk factors, in women with early stage breast cancer. IV. In-breast local failure and patterns of in-breast failure. V. Ipsilateral regional nodal failure. VI. Toxicity and morbidity. VII. Relapse-free survival. VIII. Overall survival. OUTLINE: Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy. After completion of study treatment, patients are followed up within 6 weeks and then every 6 months for 3 years and yearly for 2 years.

Conditions

• Stage IA Breast Cancer
• Stage IIA Breast Cancer

Interventions

Type	Name	Description
RADIATION	Intraoperative Radiation Therapy	Undergo IORT
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2012-05-18
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2012-04-04
• Last updated: 2026-03-18

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated device study