Intraoperative Radiation Therapy in Early Stage Breast Cancer (IORTBreast)

April 24, 2019 updated by: Michelle Yao, Benaroya Research Institute

Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer

Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of:

  • Local recurrence in early stage breast cancer patients treated with IORT.
  • Toxicity associated with IORT.
  • Long-term disease-specific and overall survival
  • Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.
  • Quality of life in patients treated with IORT.
  • Health care costs associated with IORT.

Study Type

Interventional

Enrollment (Actual)

500

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
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

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

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

General Inclusion Criteria

  1. Age ≥ 45 years.
  2. Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).
  3. Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.

Exclusion Criteria:

  1. Scleroderma, systemic sclerosis and active lupus.
  2. Participation in an investigational drug or device study.
  3. Previous ipsilateral radiation to the thorax or breast.
  4. Multifocal breast cancer.
  5. Pregnant patients.
  6. Patient not competent to provide informed consent.
  7. Neoadjuvant systemic therapy.
  8. Lymphovascular invasion on biopsy pathology

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Treatment
Patients treated with intraoperative radiation therapy at the time of partial mastectomy.
Radiation: Intraoperative Radiation Therapy
Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer
Other Names:
  • IORT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Disease Relapse
Time Frame: 10 years
Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence. In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease. Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease specific and overall survival
Time Frame: 10 years
Disease specific and overall survival will be obtained for all patients in the study.
10 years

Collaborators and Investigators

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

Sponsor

Benaroya Research Institute

Investigators

  • Principal Investigator: Janie Grumley, MD, Virginia Mason Medical Center

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)

July 30, 2018

Study Completion (ACTUAL)

July 31, 2018

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 14, 2014

First Posted (ESTIMATE)

October 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11143

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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