Single Fraction Intraoperative Radiotherapy

Not Applicable

Completed

• Conditions: Stage I Breast Carcinoma; Stage 0 Breast Carcinoma; Stage II Breast Carcinoma; Invasive Ductal and Invasive Lobular Breast Carcinoma
• Interventions: Procedure: Intraoperative Radiotherapy

• Registration Number: NCT01688388
• Lead Sponsor: St. Joseph Hospital of Orange

Brief Summary

This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.

Detailed Description

For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it) followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Primary Completion: 2016-02
• Study Completion: 2022-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma in situ
• Age > 40 years
• Karnofsky performance status > 70%
• Tumor. Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm
• Nodal Status: preoperatively N0
• Clear surgical margins: R0
• All grades G1 - G3
• Any hormonal receptor and HER-2 status
• Informed consent

Exclusion Criteria

• Gender: male
• Tumor size: more than 2.5 cm
• Nodal status greater than or equal to N1 pathologically
• Multicentricity
• Previous radiotherapy to the involved breast
• Karnofsky Index < 70%
• Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
• Distant metastases
• Pregnancy in woman of child bearing age
• Unable to provide written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IORT Arm	Intraoperative Radiotherapy	Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.

Primary Outcome Measures

Name	Time	Method
Toxicity Assessment	5 years	Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system: * End of initial surgical phase: Week 1, 4; * First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months

Secondary Outcome Measures

Name	Time	Method
Recurrence Assessment	5 years	Recurrence is assessed at month 6, 12, 24, 36, 48, 60
Cosmetic Evaluation	5 years	Assessment of cosmetic outcome according to 5-point scoring system; * Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60; * At yearly follow-up (photodocumentation in standardized positions) for 5 years

Trial Locations

Locations (1)

St. Joseph Hospital of Orange; 🇺🇸 Orange, California, United States