Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT00983684
Protocol/serial number
HTA 07/60/49
Study information
Scientific title
TARGIT: a randomised controlled trial to compare targeted intra-operative radiotherapy with conventional post-operative radiotherapy after conservative breast surgery for women with early stage breast cancer
Acronym
TARGIT
Study hypothesis
Current hypothesis as of 17/05/2010:
TARGIT is an international randomised clinical trial designed to test the hypothesis that the strategy of delivering a single dose of targeted intraoperative radiotherapy (IORT) in patients eligible for breast conserving therapy (with the addition of whole breast radiotherapy in those patients at high risk of recurrence elsewhere in the breast [e.g. lobular carcinomas and extensive intraductal component]) is equivalent to a conventional course of post-operative external beam radiotherapy (EBRT). The primary endpoints are local and loco-regional recurrence rates. It is a pragmatic trial in which each participating centre has the option to define more restrictive entry criteria than in the core protocol. Only centres with access to the Intrabeam® (Carl Zeiss) enter patients into the trial. Eligible patients are those with tumours of good prognosis suitable for breast conserving surgery. After giving consent patients are randomised to either IORT or to EBRT. They may receive any other adjuvant treatments as deemed necessary, except for neoadjuvant therapy. The protocol requires that patients be followed at six monthly intervals for five years and then annually.
Previous hypothesis:
The TARGIT trial is an international randomized controlled clinical trial comparing single-day targeted intraoperative radiotherapy to conventional postoperative radiotherapy for women with early stage invasive breast cancer treatable with lumpectomy. Currently, single-day targeted intraoperative radiotherapy is investigational, which means that this treatment is still under evaluation as a treatment for breast cancer. Although small studies indicate that single-day targeted intraoperative radiotherapy is as safe and effective as conventional postoperative radiotherapy for certain patients, a long-term, scientific, head-to-head comparison of the two treatments is needed to determine if they are truly equal. This is the purpose of the TARGIT trial.
Further reading:
More details, including a list of publications, reviews, publicitiy articles, case reports and presentations, can be found at: http://www.dundee.ac.uk/surgery/targit/targitpapers.htm
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/076049
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0007/51892/PRO-07-60-49.pdf
Ethics approval(s)
University College Hospitals Ethics Committee, 25/02/2000, ref: MREC No. 99/0307
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
http://www.dundee.ac.uk/surgery/targit/Dundee%20SIS%20Single%20Procedure%20v2.pdf; http://www.dundee.ac.uk/surgery/targit/Dundee%20SIS%20Subsequent%20Procedure%20v2.pdf
Condition
Breast cancer
Intervention
Current interventions as of 17/05/2010:
Intrabeam device: a dose of 20 Gy at the surface of the applicator or 6 Gy at 1 cm (in water) is prescribed by the radiation oncologist and delivered to the breast tissue. This takes approximately 30 minutes, depending on the size of the applicator.
Post-operative radiotherapy: all patients randomised to receive conventional radiotherapy within this trial should be treated in accordance with a pre-specified policy. Dosage should only be applied to the breast; axillary, supra-clavicular and internal mammary nodes should not generally be irradiated by discrete fields.
Previous interventions:
Use of the Intrabeam device to deliver intra-operative radiotherapy after wide local excision (WLE) as compared to delivery of standard external beam radiotherapy (EBRT).
In the TARGIT trial, half of the participants will receive single-day targeted intraoperative radiotherapy given at the time of surgery. The other half will receive conventional postoperative radiotherapy given over a 6-7 week period beginning after surgery.
Intervention type
Other
Primary outcome measure
Added 17/05/2010:
Local relapse within the treated breast
Secondary outcome measures
Added 17/05/2010:
1. Site of relapse within the breast
2. Relapse-free survival and overall survival
3. Local toxicity/morbidity
Overall study start date
01/03/2000
Overall study end date
31/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 17/05/2010:
1. Age 45 years or older
2. Operable invasive breast cancer (T1 and small T2, N0-1, M0) confirmed by cytological or histological examination
3. Suitable for breast conserving surgery
4. Previously diagnosed and treated contralateral breast cancer may be entered but will be randomised to a separate stratum
5. Available for regular follow-up for at least 10 years
Note: Individual centres may wish to restrict entry to a more exactly defined subset of patients, in which case only patients with these characteristics may be entered by that particular centre. For example, centres may decide at outset to recruit only women over 50 or even over 65 years of age. Such policies must be pre-defined in writing and approved by the International Steering Committee.
Previous inclusion criteria:
Eligible patients are those with tumours of good prognosis suitable for breast conserving surgery.
Prior to joining the study, women must meet with the study investigators to determine if they qualify for the TARGIT trial. This evaluation will include a physical examination, review of mammograms and ultrasounds, and review of pathology results. Additional radiology studies (mammograms, ultrasounds, and/or breast MRI) may also be requested prior to determining eligibility for the study.
In order to participate in the TARGIT trial, the following criteria must be met:
1. Age 40 or older
2. Invasive (also called infiltrating) breast cancer
3. Breast cancer measuring 3 cm (1-1/8 in) or less
4. Breast cancer treatable with lumpectomy
5. Capable of receiving breast radiotherapy (not pregnant, no history of previous radiotherapy to the same breast, no connective tissue disorder)
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
3432
Total final enrolment
2298
Participant exclusion criteria
Current exclusion criteria as of 17/05/2010:
1. More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography or ultrasonography
2. Bilateral breast cancer at the time of diagnosis
3. Ipsilateral breast had a previous cancer and/or irradiation
4. Patients known to have BRCA2 gene mutations, but testing for gene mutations is not required
5. Lobular cancer or extensive intraductal component (EIC ≥25% of the tumour is intraductal) on core biopsy or initial pathology (if performed)
6. Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with neoadjuvant intent of reducing tumour size should be excluded; those given short duration (up to 4 weeks) systemic therapy can be included
7. Patients presenting with gross nodal disease, considered to be clinically malignant or proven cytologically or by scanning. In general, four or more positive nodes or extranodal spread are not suitable for TARGIT alone and should receive EBRT as well. However, individual centres may decide that anything more than micrometastasis should receive EBRT
8. Patients with any severe concomitant disease that may limit their life expectancy
9. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater
10. Any factor included as exclusion criterion in the local centre's Treatment Policy. This is particularly relevant to patients entered into the post-pathology stratum
11. No more than 30 days can have elapsed between last breast cancer surgery (not axillary) and entry into the trial for patients in the post-pathology stratification
Previous exclusion criteria:
1. Multiple areas of cancer within the breast
2. Cancer in both breasts
3. Diagnostic biopsy shows extensive non-invasive cancer (DCIS or Ductal Carcinoma in Situ)
4. Lymph nodes contain cancer metastasis
Recruitment start date
01/03/2000
Recruitment end date
31/03/2012
Locations
Countries of recruitment
Australia, Canada, Denmark, England, France, Germany, Italy, Norway, Poland, Switzerland, United Kingdom, United States of America
Study participating centre
UCL Medical School
London
N19 5LW
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Gower Street
London
WC1E 6BT
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | pilot study results | 01/08/2001 | Yes | No | |
| Other publications | discussion of operative technique | 01/06/2002 | Yes | No | |
| Results article | Australian results | 01/12/2004 | Yes | No | |
| Results article | German results | 01/07/2005 | Yes | No | |
| Results article | German results on long-term toxicity | 01/10/2006 | Yes | No | |
| Results article | results on recurrence rates | 01/12/2006 | Yes | No | |
| Results article | international results | 01/10/2007 | Yes | No | |
| Results article | environmental and social benefits results | 09/05/2016 | Yes | No | |
| Results article | results | 01/09/2016 | Yes | No | |
| Results article | long-term results | 19/08/2020 | 24/08/2020 | Yes | No |
| Results article | new insights results | 01/05/2021 | 27/05/2021 | Yes | No |
| Plain English results | 31/03/2022 | No | Yes |