Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

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 Women can ask to be withdrawn from the study at any time.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, The London Clinic, and Royal Hampshire County Hospital (UK)

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 July 2022. 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?
1. Prof. J S Vaidya
2. Nick Roberts

Trial website

Contact information



Primary contact

Prof JS Vaidya


Contact details

Whittington Health
Royal Free Hospital
University College London Hospital
United Kingdom
+44 (0)207 034 8890 and +44 (0)207 288 5831



Additional contact

Mr Nick Roberts


Contact details

Surgical & Interventional Trials Unit (SITU)
Division of Surgery & Interventional Science
Faculty of Medical Sciences
University College London
United Kingdom
+44 (0)20 7679 9280

Additional identifiers

EudraCT number number


Protocol/serial number


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



Study hypothesis

Early data from our HTA funded randomised controlled trial (TARGIT A) registered under 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


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet


Early breast cancer suitable for breast conserving surgery


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

Intervention type



Not Applicable

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

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

Participant type


Age group




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


Recruitment end date



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
United Kingdom

Sponsor information


University College London (UK)

Sponsor details

Joint Research Office
Ground Floor
Rosenheim Wing
25 Grafton Way
United Kingdom
+44 (0)20 7679 6639

Sponsor type




Funder type


Funder name

Royal Free Charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/11/2018: The following changes were made to the trial record: 1. Study contacts updated. 2. number added. 3. The recruitment end date was changed from 01/07/2015 to 31/07/2022. 4. The overall trial end date was changed from 01/07/2023 to 31/07/2032.