NCT03583619

Randomized Trial of Accelerated Partial Breast Irradiation

A Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.

Detailed description

This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.

Conditions

• Breast Neoplasms
• Neoplasm Recurrence, Local

Interventions

Type	Name	Description
RADIATION	APBI	Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.
RADIATION	WBI	Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.

Timeline

• Start date: 2017-07-19
• Primary completion: 2019-01-11
• Completion: 2020-03-23
• First posted: 2018-07-11
• Last updated: 2026-01-26

Locations

1 site across 1 country: China