Vokes Everett E, Senan Suresh, Treat Joseph A, Iscoe Neill A
University of Chicago, IL, USA.
Clin Lung Cancer. 2009 May;10(3):193-8. doi: 10.3816/CLC.2009.n.027.
This clinical trial summary provides the background and rationale for a randomized trial examining the benefits of pemetrexed/ cisplatin chemotherapy combined with radiation followed by consolidation pemetrexed in patients with unresectable stage IIIA/B non-small-cell lung cancer. The rationale for the selection of the control arm is provided, and study design limitations are discussed. The primary outcome is survival, and secondary outcomes include progression-free survival, toxicities, and 1-, 2-, and 3-year survival rates. Radiation quality control is a key component of the trial.
本临床试验总结提供了一项随机试验的背景和基本原理,该试验旨在研究培美曲塞/顺铂化疗联合放疗,随后进行培美曲塞巩固治疗对不可切除的IIIA/B期非小细胞肺癌患者的益处。文中提供了选择对照组的基本原理,并讨论了研究设计的局限性。主要结局是生存率,次要结局包括无进展生存期、毒性以及1年、2年和3年生存率。放射质量控制是该试验的关键组成部分。