Condition: Breast Cancer · Sponsor: Ruijin Hospital
For patients with breast cancer, regional nodal irradiation (RNI) can significantly reduce the risks of recurrence and mortality. Moderate hypofractionated regimens (40 to 42.5 Gy in 15 to 16 fractions over 3 weeks) is the established standard of care for RNI. Nevertheless, for the majority of patients, a three - week treatment duration is still regarded as lengthy. Although the ultra-hypofractionated regimen (26 Gy in 5 fractions over 1 week) has been proven non-inferior to the moderate hypofractionated regimen for whole breast irradiation, unambiguous evidence supporting its use in comprehensive RNI remains lacking, especially in high risk patients requiring internal mammary node irradiation (IMNI). This prospective, non-inferiority trial is designed to address this evidence gap by evaluating whether a one-week, ultra-hypofractionated regimen (26 Gy in 5 fractions) is non-inferior to the three-week regimen (40 Gy in 15 fractions) for comprehensive RNI, including IMNI.
This description comes directly from the study's public registry record.
Lu Cao, PhD, MD · +86 147824551281 · cl11879@rjh.com.cn
Jia-Yi Chen, PhD, MD · cjy11756@rjh.com.cn
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| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07527689