We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Intraoperative Radiation Therapy in Early Stage Breast Cancer (IORTBreast)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02266602
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : April 26, 2019
Information provided by (Responsible Party):
Michelle Yao, Benaroya Research Institute

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

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Intraoperative Radiation Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer
Study Start Date : February 2012
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/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 Name: IORT

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Disease specific and overall survival [ Time Frame: 10 years ]
    Disease specific and overall survival will be obtained for all patients in the study.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266602

Layout table for location information
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
Layout table for investigator information
Principal Investigator: Janie Grumley, MD Virginia Mason Medical Center
Layout table for additonal information
Responsible Party: Michelle Yao, MD, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT02266602    
Other Study ID Numbers: 11143
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Keywords provided by Michelle Yao, Benaroya Research Institute:
Breast Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases