An observational study in Early Stage Breast Cancer, Neoplasm of the Breast and Breast Tumor, sponsored by TriHealth Inc.. Terminated at 1 site in United States. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by TriHealth Inc. · Observational
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,
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 16 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women, aged 45 and greater who have been diagnosed with early stage invasive breast cancer that is suitable for breast conserving surgery.
Exclusion Criteria:
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.
Time frame: 6 months after IORT through year 10
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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TriHealth Inc.