NCT00793962

A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 810 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.

Detailed description

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	hypofractionation radiotherapy	radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
RADIATION	conventional fractionation radiotherapy	50Gy/25/f/5w

Timeline

• Start date: 2008-06-01
• Primary completion: 2016-05-01
• Completion: 2018-09-01
• First posted: 2008-11-19
• Last updated: 2018-10-11

Locations

1 site across 1 country: China