NCT02266602

Intraoperative Radiation Therapy in Early Stage Breast Cancer

Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Benaroya Research Institute · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.

Detailed description

The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of: * Local recurrence in early stage breast cancer patients treated with IORT. * Toxicity associated with IORT. * Long-term disease-specific and overall survival * Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT. * Quality of life in patients treated with IORT. * Health care costs associated with IORT.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Intraoperative Radiation Therapy	Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer

Timeline

• Start date: 2012-02-01
• Primary completion: 2018-07-30
• Completion: 2018-07-31
• First posted: 2014-10-17
• Last updated: 2019-04-26

Locations

1 site across 1 country: United States