Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT) (TARGIT)

August 20, 2018 updated by: Angela N Fellner PhD CCRP, TriHealth Inc.

Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT)

The purpose of this study is to create a registry to evaluate the use of intra-operative radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery,

Study Overview

Status

Terminated

Conditions

Detailed Description

A registry trial has been designed and modeled after the original successful TARGIT protocol, to continue the use of IORT for a select population of women, and to follow outcomes with regards to local and regional control, toxicity and morbidity. Patients selected for breast conserving surgery, who are considered to have a low risk of local recurrence, are eligible for this registry trial once their informed consent is obtained. This single arm cohort study allows entry of patients who have been diagnosed with early stage breast cancer and whose clinical stage is suitable for treating conservatively (small tumor and no gross nodal involvement). Tumors should not be more than 3.5 cm in size.

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Mary Jo Cropper Family Center for Breast Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women, aged 45 and greater who have been diagnosed with early stage invasive breast cancer that is suitable for breast conserving surgery.

Description

Inclusion Criteria:

  • Female
  • Age 45 or greater
  • Diagnosed with operable invasive breast cancer, T1 and T2 (< 3.5 cm), N0, M0, confirmed by cytological or histological examination
  • Suited for breast conserving surgery
  • Have had an ipsilateral (same side as current cancer) diagnostic mammogram within 12 months of enrollment

Exclusion Criteria:

  • age 44 or less
  • 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, DCIS) as assessed on surgical pathologic lumpectomy specimen
  • Multicentric cancer in the same breast not amenable to excision 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
  • Neoadjuvant treatment (hormones or chemotherapy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-breast local failure and patterns of in-breast failure
Time Frame: 6 months after IORT through year 10
In-breast local failure is defined as recurrence of cancer in the ipsilateral (same side) breast. Following IORT, patients will be monitored every 6 months for 3 years, and then annually in years 4 and 5 to determine if cancer has returned. In years 6 through 10 medical records will be reviewed to obtain information on participants' breast cancer status.
6 months after IORT through year 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Collaborators

TriHealth Hatton Research Institute
Bethesda North Hospital Foundation

Investigators

  • Principal Investigator: Ching Ho, MD PhD, Mary Jo Cropper Family Center for Breast Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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