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Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by University of California, San Francisco
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01570998
First received: March 2, 2012
Last updated: April 28, 2017
Last verified: April 2017
  Purpose
This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.

Condition Intervention Phase
Stage IA Breast Cancer Stage IIA Breast Cancer Radiation: Intraoperative Radiation Therapy Other: Laboratory Biomarker Analysis Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Incidence of local recurrence [ Time Frame: Up to 5 years ]
    Statistical analysis of this study is primarily descriptive and exploratory. An "intent to treat" analysis will be conducted mainly using the log-rank test and Kaplan-Meier to compare hazard rates. Other parametric and nonparametric methods of analysis will also be used.


Estimated Enrollment: 750
Study Start Date: May 2012
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (IORT)
Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.
Radiation: Intraoperative Radiation Therapy
Undergo IORT
Other Names:
  • Intraoperative Radiotherapy
  • IORT
  • radiotherapy, intraoperative
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To establish eligibility criteria based on previously published trials and studies in order to allow women who meet these criteria to receive intraoperative radiation therapy (IORT) on an Institutional Review Board (IRB)-approved protocol.

II. To systematically collect and assess acute and long-term toxicity and outcomes in larger cohort of patients.

III. To study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery, with or without whole breast radiation, as indicated by pathologic risk factors, in women with early stage breast cancer.

IV. In-breast local failure and patterns of in-breast failure. V. Ipsilateral regional nodal failure. VI. Toxicity and morbidity. VII. Relapse-free survival. VIII. Overall survival.

OUTLINE:

Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.

After completion of study treatment, patients are followed up within 6 weeks and then every 6 months for 3 years and yearly for 2 years.

  Eligibility

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

Inclusion Criteria:

  • Suitable for breast conserving surgery
  • T1 and T2 (< 3.5 cm), N0, M0

Exclusion Criteria:

  • Axillary lymph node positive breast cancer
  • Invasive lobular cancer
  • Tumor size > 3.5 cm
  • Extensive intraductal component (EIC >= 25% of the lumpectomy specimen involved with ductal carcinoma in situ), as assessed on surgical pathologic lumpectomy specimen
  • Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
  • Inability to assess pathologic margin status
  • Synchronous bilateral breast cancer at the time of diagnosis
  • Ipsilateral breast had a previous cancer and/or prior in-field radiation
  • Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required)
  • Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size
  • Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater
  • Any factor included as exclusion criteria in the participating center's treatment policy statement
  • Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy):

    • Patients under the age of 50
    • Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
    • HER2 positive (as defined in Treatment Policy under "HER2")
    • Lymphovascular invasion
    • High grade
    • Tumors > 3 cm
    • Node positive patients
    • Prior chemotherapy or hormone therapy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570998

Locations
United States, California
Alta Bates Summit Medical Center-Herrick Campus Not yet recruiting
Berkeley, California, United States, 94704
Contact: Christine S. Chung    510-204-5311    chungc1@sutterhealth.org   
Principal Investigator: Christine S. Chung         
California Hospital Medical Center Not yet recruiting
Los Angeles, California, United States, 90015
Contact: Dennis R. Holmes    213-742-6400    dennis.holmes@dignityhealth.org   
Principal Investigator: Dennis R. Holmes         
UCSF Medical Center-Mount Zion Recruiting
San Francisco, California, United States, 94115
Contact: Michael D. Alvarado    415-353-7111      
Principal Investigator: Michael D. Alvarado         
John Muir Medical Center-Walnut Creek Recruiting
Walnut Creek, California, United States, 94598
Contact: Marjaneh Moini    925-947-3250    marjaneh.moini_MD@johnmuirhealth.com   
Principal Investigator: Marjaneh Moini         
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, D.C., District of Columbia, United States, 20007
Contact: Shawna C. Willey    202-444-0241    scw9@gunet.georgetown.edu   
Principal Investigator: Shawna C. Willey         
MedStar Washington Hospital Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Marc E. Boisvert    202-877-7937    marc.e.boisvert@medstar.net   
Principal Investigator: Marc E. Boisvert         
United States, Florida
Cleveland Clinic Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Stephanie Valente    216-444-0769    valents3@ccf.org   
Principal Investigator: Stephanie Valente         
Holy Cross Hospital Not yet recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Joseph J. Casey    954-772-6700    joseph.casey@holy-cross.com   
Principal Investigator: Joseph J. Casey         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Eric D. Donnelly    312-926-4247    edonnell@nmff.org   
Principal Investigator: Eric D. Donnelly         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: William Small    708-216-2559    wmsamll@lumc.edu   
Principal Investigator: William Small         
United States, Indiana
Community Cancer Center South Recruiting
Indianapolis, Indiana, United States, 46227
Contact: Susan C. Lottich    317-497-6922    greatkarma2006@yahoo.com   
Principal Investigator: Susan C. Lottich         
United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: Neil B. Friedman    410-332-9330    nfriedman@mdmercy.com   
Principal Investigator: Neil B. Friedman         
United States, Massachusetts
Lahey Hospital and Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Rebecca C. Yang    978-538-4039    rebecca.c.yang@lahey.org   
Principal Investigator: Rebecca C. Yang         
United States, New York
Community Hospital at Dobbs Ferry Recruiting
Dobbs Ferry, New York, United States, 10522
Contact: Pond R. Kelemen    914-693-5025    prkelemen@hotmail.com   
Principal Investigator: Pond R. Kelemen         
Cornell University Not yet recruiting
Ithaca, New York, United States, 14850-2488
Contact: Mary K. Hayes    212-746-3610    mkh2001@med.cornell.edu   
Principal Investigator: Mary K. Hayes         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Eileen P. Connolly    212-305-5547    epc2116@cumc.columbia.edu   
Principal Investigator: Eileen P. Connolly         
Vassar Brothers Medical Center Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Angela J. Keleher    845-483-6500    akeleher@health-quest.org   
Principal Investigator: Angela J. Keleher         
United States, Pennsylvania
Saint Luke's Hospital-Anderson Campus Recruiting
Easton, Pennsylvania, United States, 18045
Contact: Lee B. Riley    484-503-4105    rileyl@slhn.org   
Principal Investigator: Lee B. Riley         
United States, Virginia
Sentara Port Warwick Not yet recruiting
Newport News, Virginia, United States, 23606
Contact: Richard A. Hoefer    757-594-1806    rahoefer@sentara.com   
Principal Investigator: Richard A. Hoefer         
United States, Wisconsin
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: William L. Owens    920-288-8480    william.owens@aurora.org   
Principal Investigator: William L. Owens         
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michael Alvarado UCSF Medical Center-Mount Zion
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01570998     History of Changes
Other Study ID Numbers: 117515
NCI-2017-00461 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
11-06843
117515 ( Other Identifier: UCSF Medical Center-Mount Zion )
P30CA082103 ( US NIH Grant/Contract Award Number )
Study First Received: March 2, 2012
Last Updated: April 28, 2017

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

ClinicalTrials.gov processed this record on June 28, 2017