Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    TARGIT-US
Previous Study | Return to List | Next Study

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01570998
Recruitment Status : Recruiting
First Posted : April 4, 2012
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
Stage IA Breast Cancer Stage IIA Breast Cancer Radiation: Intraoperative Radiation Therapy Other: Laboratory Biomarker Analysis Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : May 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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
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")
    • Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2")
    • Lymphovascular invasion
    • High grade
    • Tumors > 3 cm
    • Node positive patients
    • Prior chemotherapy or hormone therapy

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): NCT01570998


Contacts
Layout table for location contacts
Contact: Lauren Dickey 877-827-3222 cancertrials@ucsf.edu

Locations
Show Show 24 study locations
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Michael Alvarado, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form  [PDF] December 17, 2012

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01570998    
Other Study ID Numbers: 117515
NCI-2017-00461 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases