Spots Global Cancer Trial Database for Accelerated Partial Breast Irradiation for Early Breast Cancer

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Trial Identification

Brief Title: Accelerated Partial Breast Irradiation for Early Breast Cancer

Official Title: A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.

Study ID: NCT00418210

Conditions

Breast Cancer

Interventions

Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)

Study Description

Brief Summary: Hypothesis: 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.

Detailed Description: 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. Secondary objectives: * 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.