Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)

NCT02364960 | Terminated

• 1 other identifier: 14-047
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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,

Conditions

Early Stage Breast Cancer; Neoplasm of the Breast; Breast Tumor

Outcome Measures

Primary Outcomes (1)

• In-breast local failure and patterns of in-breast failure

  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

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• TriHealth Inc.: lead
• TriHealth Hatton Research Institute: collaborator
• Bethesda North Hospital Foundation: collaborator

Study Sites (1)

Mary Jo Cropper Family Center for Breast Care

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ching Ho, MD PhD

  Mary Jo Cropper Family Center for Breast Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Mary Jo Cropper Family Center for Breast Care

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 18, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)