NCT02370797

Node Negative, Invasive Breast Cancer Single Fraction IOERT

Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Avera McKennan Hospital & University Health Center · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

Detailed description

See points VIII inclusion/exclusion criteria Operation: * Lumpectomy, steninal node biopsy * IOeRT After Surgery: * Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required. * Chemotherapy (if indicated) * Hormone therapy (if indicated) Follow-Up * Visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates. * Assessements of acute toxicity according to CTC-toxicity scoring system * Assessments of late toxicity according to LENT-SOMA scoring systems * Assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Single Fraction IOeRT	A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.

Timeline

• Start date: 2015-02-01
• Primary completion: 2029-02-01
• Completion: 2029-05-01
• First posted: 2015-02-25
• Last updated: 2025-01-28

Locations

1 site across 1 country: United States