NCT02947425

TARGeted Intraoperative radioTherapy (TARGIT) Registry Database

TARGIT R: TARGeted Intraoperative radioTherapy (TARGIT) Registry Database

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early-Stage Breast Carcinoma

Timeline

• Start date: 2013-07-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2016-10-27
• Last updated: 2019-10-02

Locations

3 sites across 1 country: United Kingdom