NCT00156130

Accelerated Radiotherapy Outcomes in Women

Accelerated Radiotherapy Outcomes in Women (Long Term Outcomes of a Randomized Trial of Breast Irradiation Schedules After Lumpectomy in Women With Node-Negative Breast Cancer)(AROW)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,234 (actual)
• Sponsor: Ontario Clinical Oncology Group (OCOG) · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is evaluating the long-term outcomes of women in a randomized trial that compared accelerated whole breast irradiation (42.5 Gy in 16 fractions over 22 days) to a longer conventional schedule of whole breast irradiation (50 Gy in 25 fractions over 35 days) following breast-conserving surgery. The outcomes evaluated will include cosmetic outcome and cardiac disease as a measure of late radiation morbidity and local breast recurrence as a measure of effectiveness.

Detailed description

This study is evaluating the long-term outcomes of women in a randomized trial that compared accelerated whole breast irradiation (42.5 Gy in 16 fractions over 22 days) to a longer conventional schedule of whole breast irradiation (50 Gy in 25 fractions over 35 days) following breast-conserving surgery. The results reported at 5 years demonstrated equivalence for these two different radiation schedules for the effect of local recurrence in the breast and cosmetic outcome. Emerging data has suggested that accelerated or shorter radiation schedules may potentially be associated with an increased risk of late morbidity of the skin, soft tissue and the heart at 10 years and beyond. The purpose of this study is to evaluate the long term outcomes of women randomized in the trial. The outcomes evaluated will include cosmetic outcome and cardiac disease as a measure of late radiation morbidity and local breast recurrence as a measure of effectiveness.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Conventional radiotherapy schedule	50 Gy in 25 fractions over 35 days
RADIATION	Accelarated radiotherapy schedule	42.5 Gy in 16 fractions over 22 days

Timeline

• Start date: 2003-10-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2005-09-12
• Last updated: 2016-05-09

Locations

11 sites across 1 country: Canada