Comparison of Intra-operative Radiotherapy With Post-operative Radiotherapy for Women With Early Breast Cancer (TARGIT)
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|ClinicalTrials.gov Identifier: NCT00983684|
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : December 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Invasive Breast Cancer Breast Cancer||Device: Intrabeam Radiation: Post-operative radiotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3451 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2000|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
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
- 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 ]
- 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 ]
- 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 ]
- Local toxicity/morbidity [ Time Frame: 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983684
|Clinical Trials Group|
|London, United Kingdom, N19 5LW|
|Principal Investigator:||Jeffrey S Tobias, MD FRCP FRCR||University College London Hospitals|