TARGIT R: TARGeted Intraoperative radioTherapy (TARGIT) Registry database

Not Applicable

• Conditions: Early breast cancer suitable for breast conserving surgery; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN91179875
• Lead Sponsor: niversity College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-21
• Last Update Posted: 5 August 2022
• Study Completion: 2032-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

1. Recommended treatment by Multi-Disciplinary Team (MDT)
2. Consent has been obtained for data to be collected

Exclusion Criteria

Under 18 years of age

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.