Single Fraction Intraoperative Radiotherapy

Providence

Status: Completed

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

Treatments: Procedure: Intraoperative Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01688388

12-001 Single Fraction IORT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: Female

Ages: 41 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

IORT Arm

Experimental group

Description:

Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.

Treatment:

Procedure: Intraoperative Radiotherapy