TARGeted Intraoperative radioTherapy (TARGIT) Registry Database

• Conditions: Early-Stage Breast Carcinoma

• Registration Number: NCT02947425
• Lead Sponsor: University College, London

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events related to the primary treatment of the breast cancer.	Five years	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.
Local tumour control (defined as no recurrent tumour in the ipsilateral breast)	Five years	Confirmation that the TARGIT technique results in an acceptably low rate of local recurrence when given outside of a randomised controlled trial.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Royal Free Hospital; 🇬🇧 London, United Kingdom

The London Clinic; 🇬🇧 London, United Kingdom

Royal Hampshire County Hospital; 🇬🇧 Winchester, United Kingdom