NCT02958033

Shandong Cancer Hospital Affiliated to Shandong University

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.

Conditions

• Early-stage Breast Cancer
• Breast Conserving Surgery

Interventions

Type	Name	Description
RADIATION	Whole Breast irradiation Plus simultaneous tumor bed Boost	hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-11-01
• Completion: 2024-11-01
• First posted: 2016-11-08
• Last updated: 2016-11-08

Locations

1 site across 1 country: China