Condition category
Cancer
Date applied
24/04/2013
Date assigned
21/05/2013
Last edited
07/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We have set up a database of patients with early breast cancer who are being treated with radiotherapy during surgery. More than 2000 women have already received this treatment in clinical trials. We want to 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. Our aim is to monitor the long-term effectiveness and safety of the technique.

Who can participate?
Women over the age of 45 with early breast cancer where the doctors looking after them feel that the treatment is suitable. There is no upper age limit. This study will be made available to all hospitals in the UK, Europe and elsewhere, but they must have the special equipment in place.

What does the study involve?
Women selected for this treatment will be asked to read an information leaflet and sign a consent form. If you wish to participate, surgery and radiotherapy will be performed at the same time. Information about the patient, the breast cancer and the treatment will then be sent to a central office in University College London. The data will be kept securely, and any information that might identify an individual (such as name) will not be released to anyone outside of the study team. We will ask for updates on the patients' health status about once per year for at least 10 years.

What are the possible benefits and risks of participating?
Your doctor will explain to you the risks and benefits of radiotherapy. One of the benefits of having the radiotherapy during surgery is that you do not have to attend the radiotherapy centre for treatment every day for several weeks. However, some hospitals might have a rule that only women taking part in the study can be offered the treatment. Women can ask to be withdrawn from the study at any time.

Where is the study run from?
University College London in collaboration with Royal Free Hospital, London.

When is study starting and how long is it expected to run for?
It is anticipated that recruitment will start mid-2013 and will continue to at least mid-2015. Data will be collected from participating women for at least 10 years.

Who is funding the study?
Initial funding has been provided by a charity at the Royal Free Hospital in London. If the study proceeds satisfactorily, then further funding will be sought. Data collected during the study will be maintained on the secure database in University College London.

Who is the main contact?
Dr Mo Keshtgar
m.keshtgar@ucl.ac.uk
Dr Norman Williams
norman.williams@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mohammed Keshtgar

ORCID ID

Contact details

Royal Free London Foundation Trust
University College London
The Breast Unit
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
+44 (0)20 7830 2758
m.keshtgar@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

version 1.0

Study information

Scientific title

TARGIT R: Initiation and maintenance of a registry database of patients treated with TARGeted Intraoperative radiation Therapy using intrabeam (TARGIT) following breast conserving surgery for early breast cancer

Acronym

TARGIT R

Study hypothesis

Early data from our HTA funded randomised controlled trial (TARGIT A) registered under ISRCTN34086741 (http://www.controlled-trials.com/ISRCTN34086741) has shown that treatment with targeted intraoperative radiation therapy using Intrabeam (TARGIT) following breast conserving surgery for early breast cancer is non inferior to conventional external beam radiotherapy, in terms of efficacy and safety.

In parallel with this study we gathered evidence that the technique can also be used in patients who did not meet the eligibility criteria; for example, those with collagen vascular disease where external beam radiotherapy is contraindicated. The TARGIT R study will have wider patient selection criteria and is designed to not only include patients who would have been eligible for recruitment in TARGIT A, but also patients with breast cancer in special circumstances, for example: patients with systemic lupus erythematosus, scleroderma, motor neurone disease, Parkinson's disease, ankylosing spondylitis, morbid obesity and cardiovascular or severe respiratory disease and patients who had received previous external beam radiotherapy (EBRT) (mantle radiotherapy for treatment of lymphoma or developed 2nd primary cancer in the same breast) and refuse mastectomy. With all patients, it is essential that cases are discussed at the local multidisciplinary team (MDT) meeting and if approved, TARGIT can be considered for these patients in a clinical research setting (TARGIT R). This will enable us to gain an understanding of how the technique works in these complex scenarios, and will provide valuable information to clinicians and important data for incorporation into NICE guidelines.

Ethics approval

NRES Committee London - Camden & Islington, 08/09/2014, ref: 14/LO/1452

Study design

Prospective observational multi-site outcome study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Early breast cancer suitable for breast conserving surgery

Intervention

Registration of patients selected for this treatment; collecting data regarding safety and toxicity on patients who have had treatment with TARGIT.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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.

Overall trial start date

01/07/2013

Overall trial end date

01/07/2023

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

The aim is to include all women treated with the technique who are not otherwise participating in a randomised controlled trial.

Participant exclusion criteria

Under 18 years of age

Recruitment start date

01/07/2013

Recruitment end date

01/07/2015

Locations

Countries of recruitment

Australia, Canada, Denmark, France, Germany, Italy, Norway, Poland, Switzerland, United Kingdom, United States of America

Trial participating centre

Royal Free London Foundation Trust
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Joint Research Office
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 6DB
United Kingdom
+44 (0)20 7679 6639
n.mcnally@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/jro

Funders

Funder type

Charity

Funder name

Royal Free Charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes