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In selected women with node-negative invasive breast cancer treated with breast conserving surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local control rate in a multicentre trial.
This is a TROG multicentre feasibility study of APBI using 3D CRT in selected women with node-negative breast cancer treated by breast conserving surgery with negative margins.
This is a one-arm feasibility study in which the primary endpoint is the feasibility rate for APBI using 3D CRT. This is defined as the proportion of eligible patients treated without a major protocol deviation. Secondary endpoints include radiation toxicity, cosmetic outcome, quality of life, time to ipsilateral breast recurrence, disease-free survival, and overall survival.
Primary objectives: To evaluate the technical feasibility and reproducibility of APBI limited to the region of the tumour bed using 3D CRT following breast conserving surgery.
- To assess the acute and long term toxicity of APBI using 3D CRT.
- To examine the cosmetic outcome of women with breast cancer treated by breast conserving surgery and APBI using 3D CRT.
- To determine the time to ipsilateral breast recurrence, disease free survival and overall survival of women with node-negative breast cancer completely resected by breast conserving surgery followed by APBI using 3D CRT.
- To assess the quality of life of women with node-negative breast cancer treated by breast conserving surgery and APBI using 3D CRT.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
APBI limited to the tumour bed using 3D CRT
Calvary Mater Newcastle
New South Wales
Active, not recruiting
Trans-Tasman Radiation Oncology Group (TROG)
Published on BioPortfolio: 2014-07-24T14:23:05-0400
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