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Intraoperative Radiation Therapy in Early Stage Breast Cancer (IORTBreast)

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ClinicalTrials.gov Identifier: NCT02266602
Recruitment Status : Recruiting
First Posted : October 17, 2014
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Janie Grumley, MD, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.



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

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


Contacts
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Contact: Janie Grumley, MD 206-223-6633 Janie.Grumley@vmmc.org

Locations
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United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Janie Grumley, MD    206-223-6633    Janie.Grumley@vmmc.org   
Sponsors and Collaborators
Benaroya Research Institute
Investigators
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Principal Investigator: Janie Grumley, MD Virginia Mason Medical Center

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Responsible Party: Janie Grumley, MD, MD, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT02266602     History of Changes
Other Study ID Numbers: 11143
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017

Keywords provided by Janie Grumley, MD, Benaroya Research Institute:
IORT
Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases