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 Women can ask to be withdrawn from the study at any time.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
jayant.vaidya@ucl.ac.uk
2. Nick Roberts
SITU.TARGITR@ucl.ac.uk
Trial website
https://www.ucl.ac.uk/surgery/research/surgical-interventional-trials-unit-situ/situ-trials-0
Contact information
Type
Scientific
Primary contact
Prof JS Vaidya
ORCID ID
Contact details
Whittington Health
Royal Free Hospital
University College London Hospital
London
NW3 2QG
United Kingdom
+44 (0)207 034 8890 and +44 (0)207 288 5831
jayant.vaidya@ucl.ac.uk
Type
Scientific
Additional contact
Mr Nick Roberts
ORCID ID
Contact details
Surgical & Interventional Trials Unit (SITU)
Division of Surgery & Interventional Science
Faculty of Medical Sciences
University College London
London
W1W 7JN
United Kingdom
+44 (0)20 7679 9280
SITU.TARGITR@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02947425
Protocol/serial number
2.0
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 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
01/07/2013
Overall trial end date
31/07/2032
Reason abandoned (if study stopped)
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
31/07/2022
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
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
Basic results (scientific)
Publication list