500
Participants
Start Date
December 1, 2024
Primary Completion Date
November 30, 2029
Study Completion Date
November 30, 2029
Postoperative radiotherapy
Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed. A tumor bed boost will be provided to patients with high-risk factors following breast-conserving surgery, at the discretion of the radiation oncologist. The tumor bed boost regimen may consist of a sequential boost of 10-16 Gy (RBE) in 5-8 fractions, or 10-13.35 Gy (RBE) in 4-5 fractions or 10.4 Gy (RBE) in 2 fractions, or a simultaneous integrated boost of 48-49.5 Gy (RBE) in 15-16 fractions.
Preoperative Radiotherapy
Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed.
Definitive Radiotherapy
Radiotherapy was delivered using IMPT or IMRT. The target volume encompassed the ipsilateral whole breast and regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions was preferred. Alternatively, a conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions was permitted. Dose escalation was applied in high-risk areas, resulting in a total prescribed dose exceeding 66 Gy (RBE) when calculated as equivalent doses in 2-Gy fractions (EQD2), with an α/β ratio of 4.
RECRUITING
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
Shandong Cancer Hospital and Institute
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
OTHER
Tongji Hospital
OTHER
Ruijin Hospital
OTHER