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Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)

Sponsor
TriHealth Inc. (Other)
Overall Status
Terminated
CT.gov ID
NCT02364960
Collaborator
TriHealth Hatton Research Institute (Other), Bethesda North Hospital Foundation (Other)
16
Enrollment
1
Location
12
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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,

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    16 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT)
    Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Jan 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. In-breast local failure and patterns of in-breast failure [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mary Jo Cropper Family Center for Breast Care Cincinnati Ohio United States 45242

    Sponsors and Collaborators

    • TriHealth Inc.
    • TriHealth Hatton Research Institute
    • Bethesda North Hospital Foundation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Angela N Fellner PhD CCRP, Co-Director, Mary Jo Cropper Family Center for Breast Care, TriHealth Inc.
    ClinicalTrials.gov Identifier:
    NCT02364960
    Other Study ID Numbers:
    • 14-047
    First Posted:
    Feb 18, 2015
    Last Update Posted:
    Aug 22, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Aug 22, 2018