Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)

Breast Tumor Clinical Trial

— TARGIT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02364960
• Other study ID #: 14-047
• Status: Terminated
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: August 2018
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Tumor
• Early Stage Breast Cancer
• Neoplasm of the Breast

Locations

Country	Name	City	State
United States	Mary Jo Cropper Family Center for Breast Care	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
TriHealth Inc.	Bethesda North Hospital Foundation, TriHealth Hatton Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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