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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02364960
Other study ID # 14-047
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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