Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)

NCT ID: NCT02364960

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-01-31

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,

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Hatton Research Institute

OTHER

Sponsor Role: collaborator

Bethesda North Hospital Foundation

UNKNOWN

Sponsor Role: collaborator

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Angela N Fellner PhD CCRP

Co-Director, Mary Jo Cropper Family Center for Breast Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ching Ho, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Mary Jo Cropper Family Center for Breast Care

Locations

Mary Jo Cropper Family Center for Breast Care

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

14-047

Identifier Type: -

Identifier Source: org_study_id