Single Fraction Intraoperative Radiotherapy

Completed · Not applicable

Conditions studied: Invasive Ductal and Invasive Lobular Breast Carcinoma, Stage 0 Breast Carcinoma, Stage I Breast Carcinoma, Stage II Breast Carcinoma

In brief

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.

Key facts

Study ID: NCT01688388
Run by: St. Joseph Hospital of Orange
People needed: 250
Starts: 2012-02-01
Expected to finish: 2022-02-01
Last updated by the study team: 2022-05-11

Who can join

Age: 41 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

St. Joseph Hospital of Orange — Orange, California, United States

Full record on ClinicalTrials.gov

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