The Design of Trials Comparing Sentinel-Node Surgery and Axillary Resection

作者：David N. Krag, Takamaru Ashikaga · 发表于：New England Journal of Medicine · 年份：2003 · DOI：10.1056/nejme038105 · 被引用次数：31 · 研究领域：Breast Cancer Treatment Studies、Cancer Genomics and Diagnostics、Statistical Methods in Clinical Trials

The technique of the sentinel-node biopsy has reoriented our understanding of the dynamics between a solid tumor and its associated lymphatic collection system.14 Moreover, the sentinel-node biopsy is an excellent way of lessening the side effects of surgery and of improving the accuracy of regional node resection. Since this method is such a fundamental change in surgical oncology, it is important to design clinical trials that will give a clear answer to the following question: Is a reduction in survival the price of limited and more accurate surgery?The design of a clinical trial starts not with a formal . . .