TARGeted Intraoperative radioTherapy (TARGIT) Registry Database (TARGIT R)

TARGIT R: TARGeted Intraoperative radioTherapy (TARGIT) Registry Database

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.

Study Overview

• Status: Unknown
• Conditions: Early-Stage Breast Carcinoma

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Royal Free Hospital
    • Contact: Norman Williams, PhD; Email: SITU.TARGITR@ucl.ac.uk
    • Principal Investigator: Sarah Needleman
  • London, United Kingdom
    • Recruiting
    • The London Clinic
    • Contact: Alistair Gifford-Moore
    • Principal Investigator: Gerald Gui
  • Winchester, United Kingdom
    • Not yet recruiting
    • Royal Hampshire County Hospital
    • Contact: Siobhan <> Laws, FRCS; Email: Siobhan.Laws@hhft.nhs.uk
    • Principal Investigator: Dick Rainsbury, FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The target population is very wide, reflecting the pragmatic nature of this study.

There will be few inclusion and exclusion criteria. Basically, any person aged over 18 with early breast cancer suitable for breast conserving surgery will be eligible. More specific entry criteria for those aged 45 or less will be defined by a participating institution's multidisciplinary team. Experience to date has indicated that there are many patients who are deemed unsuitable for a course of external beam radiotherapy whose only option is therefore mastectomy; such situations can be difficult to define in advance, and should be decided on a case-by-case basis.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Jayant S Vaidya, UCL

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: TARGIT R; ISRCTN91179875 (Other Identifier: ISRCTN registry); 14/LO/1452 (Other Identifier: UK NRES)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All requests for data sharing will adhere to the UCL Surgical & Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held at UCL on secure servers and will not be released to any third parties until the final study report has been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Royal Free Hospital, the sponsor, and funders.