TARGeted Intraoperative radioTherapy (TARGIT) Registry Database

Study Overview
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Brief Summary
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This is a prospectively registered database of patients with early breast cancer who will be treated with radiotherapy during surgery. More than 2000 women have already received this treatment in clinical trials. This study will monitor the health status of women who receive this treatment outside of a clinical trial, especially those who might not have been eligible for the original clinical trials. The aim is to confirm the long-term effectiveness and safety of the technique.

Detailed Description
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Registration of patients selected for this treatment; collecting data regarding safety and toxicity on patients who have had treatment with TARGIT. Outcomes will be measured over short and long terms. Outcome measures will include effectiveness and safety, assessed in various cohorts of patients. Core outcomes will be used for effectiveness. In addition, true recurrence (basically, ipsilateral breast tumor recurrence at the same site as the original primary) will be used as defined by Recht. Safety outcomes will be based on Common Toxicity Criteria. Budget impact analysis of IORT in subgroups of patients will be assessed. This amounts to using cost data to calculate the mean incremental (or extra) cost per person treated using intraoperative radiotherapy (IORT) versus external beam radiotherapy (EBRT) and mastectomies (where IORT could have been given instead) and then multiplying this by the total patients eligible nationally for IORT, to calculate the total expected budget impact on the NHS if IORT in these subgroups was rolled out nationally.

Official Title
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TARGIT R: TARGeted Intraoperative radioTherapy (TARGIT) Registry Database

Conditions
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Early-Stage Breast Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recommended treatment by MDT Consent has been obtained to have patient data to be collected Exclusion Criteria: Pregnancy (females who have a positive pregnancy test prior to surgery) Under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumour control (defined as no recurrent tumour in the ipsilateral breast) | Confirmation that the TARGIT technique results in an acceptably low rate of local recurrence when given outside of a randomised controlled trial. | Five years | 
| Adverse events related to the primary treatment of the breast cancer. | Confirmation that the TARGIT technique results in an acceptably low rate of safety events assessed by CTCAE v4.0 when given outside of a randomised controlled trial. | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness | Confirmation that the TARGIT technique is cost-effective as assessed by both health related quality of life (EQ5D) and cost data. | Five years |