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Intraoperative Radiation Therapy in Early Stage Breast Cancer (IORTBreast)

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ClinicalTrials.gov Identifier: NCT02266602
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Janie Grumley, MD, Benaroya Research Institute

Tracking Information
First Submitted Date  ICMJE October 10, 2014
First Posted Date  ICMJE October 17, 2014
Last Update Posted Date March 21, 2019
Study Start Date  ICMJE February 2012
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
  • 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).
  • Toxicities associated with IORT [ Time Frame: 10 years ]
    At every follow up visit, patients are assessed for toxicity or adverse events related or possibly related to IORT.
Change History Complete list of historical versions of study NCT02266602 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
Disease specific and overall survival [ Time Frame: 10 years ]
Disease specific and overall survival will be obtained for all patients in the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
  • Disease specific and overall survival [ Time Frame: 10 years ]
    Disease specific and overall survival will be obtained for all patients in the study.
  • Cosmetic Outcome [ Time Frame: 10 years ]
    At each follow up visit, patient and physician evaluating the patient will be required to fill out a comesis rating form/questionaire.
  • Financial cost of treatment [ Time Frame: 10 years ]
    Financial data from hospital billing will be obtained to assess for overall cost and patient cost.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Radiation Therapy in Early Stage Breast Cancer
Official Title  ICMJE Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Radiation: Intraoperative Radiation Therapy
Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer
Other Name: IORT
Study Arms  ICMJE Treatment
Patients treated with intraoperative radiation therapy at the time of partial mastectomy.
Intervention: Radiation: Intraoperative Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2014)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02266602
Other Study ID Numbers  ICMJE 11143
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janie Grumley, MD, Benaroya Research Institute
Study Sponsor  ICMJE Benaroya Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janie Grumley, MD Virginia Mason Medical Center
PRS Account Benaroya Research Institute
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP