TARGIT: TARGeted Intraoperative radioTherapy versus postoperative radiotherapy

• Register: ISRCTN
• Last refreshed on: 19 April 2022
• Main ID: ISRCTN34086741
• Date of registration: 21/09/2004
• Prospective Registration: No
• Primary sponsor: University College London (UK)
• Public title: TARGIT: TARGeted Intraoperative radioTherapy versus postoperative radiotherapy
• 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
• Date of first enrolment: 01/03/2000
• Target sample size: 3432
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN34086741
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)
• Phase: Phase III

Countries of recruitment

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

Contacts

• Name: Norman Williams

Key inclusion & exclusion criteria

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)

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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Breast cancer
Cancer
Malignant neoplasm of breast

Intervention(s)

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.

Primary Outcome(s)

Added 17/05/2010:
Local relapse within the treated breast

Secondary Outcome(s)

Added 17/05/2010:
1. Site of relapse within the breast
2. Relapse-free survival and overall survival
3. Local toxicity/morbidity

Secondary ID(s)

NCT00983684

HTA 07/60/49

Source(s) of Monetary Support

Health Technology Assessment Programme

Ethics review

Status:
Approval date:
Contact:

University College Hospitals Ethics Committee, 25/02/2000, ref: MREC No. 99/0307

Results

• Results available: Yes
• Date Completed: 31/03/2012