Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 8/24/2018 |
| Start Date: | January 2015 |
| End Date: | January 2016 |
Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT)
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,
radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given
intra-operatively as a single fraction after breast conserving surgery,
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.
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.
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)
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