Comparison of Intra-operative Radiotherapy With Post-operative Radiotherapy for Women With Early Breast Cancer (TARGIT)
The purpose of this study is to evaluate whether a single fraction of radiotherapy given intra-operatively and targeted to the tissues at the highest risk of local recurrence is equivalent to standard post-operative external beam radiotherapy after breast conserving surgery in women with early stage breast cancer in terms of local relapse within the treated breast.
Invasive Breast Cancer
Radiation: Post-operative radiotherapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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|
- Local relapse within the treated breast. [ Time Frame: 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months ] [ Designated as safety issue: No ]
- Site of relapse within the breast [ Time Frame: 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months ] [ Designated as safety issue: No ]
- Relapse-free survival and overall survival [ Time Frame: 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months ] [ Designated as safety issue: No ]
- Local toxicity/morbidity [ Time Frame: 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2000|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Intra-operative radiotherapy
A single fraction of radiotherapy given intra-operatively and targeted to the tissues at the highest risk of local recurrence.
A dose of 20 Gy at the surface of the applicator or 6 Gy at 1cm (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.
Other Name: IORT, targeted intra-operative radiotherapy, TARGIT
Active Comparator: Post-operative radiotherapy
Standard post-operative radiotherapy.
Radiation: 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.
Other Name: EBRT
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.
|Clinical Trials Group|
|London, United Kingdom, N19 5LW|
|Principal Investigator:||Jeffrey S Tobias, MD FRCP FRCR||University College London Hospitals|