Single Fraction Intraoperative Radiotherapy

May 9, 2022 updated by: St. Joseph Hospital of Orange

Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • St. Joseph Hospital of Orange

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IORT Arm
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.
Procedure: Intraoperative Radiotherapy
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.
Other Names:
  • IORT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity Assessment
Time Frame: 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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic Evaluation
Time Frame: 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
5 years
Recurrence Assessment
Time Frame: 5 years
Recurrence is assessed at month 6, 12, 24, 36, 48, 60
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph Hospital of Orange

Investigators

  • Study Chair: Lawrence Wagman, M.D., St. Joseph Hospital of Orange

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 14, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-001 Single Fraction IORT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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