TARGeted Intraoperative radioTherapy (TARGIT) Registry Database

TARGIT R: TARGeted Intraoperative radioTherapy (TARGIT) Registry Database

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02947425

Acronym

TARGIT R

Enrollment

2000

Registered

2016-10-27

Start date

2013-07-31

Completion date

2022-07-31

Last updated

2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-Stage Breast Carcinoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

United Kingdom

Contacts

Primary ContactNick J Roberts

SITU.TARGITR@ucl.ac.uk

Backup ContactNorman Williams, PhD