NCT00418210

Accelerated Partial Breast Irradiation for Early Breast Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)	Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT; 38.5 Gy in 3.85 Gy fractions bi-daily over 5 consecutive working days

Timeline

• Start date: 2007-08-01
• Primary completion: 2018-06-01
• Completion: 2018-08-20
• First posted: 2007-01-04
• Last updated: 2019-12-05

Locations

7 sites across 2 countries: Australia, New Zealand