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PROCLAIM研究:培美曲塞、顺铂和放射治疗后序贯培美曲塞巩固治疗与依托泊苷、顺铂和放射治疗后序贯选择的细胞毒性化疗巩固治疗在非主要为鳞状细胞组织学类型的局部晚期III期非小细胞肺癌中的III期研究。

PROCLAIM: A phase III study of pemetrexed, cisplatin, and radiation therapy followed by consolidation pemetrexed versus etoposide, cisplatin, and radiation therapy followed by consolidation cytotoxic chemotherapy of choice in locally advanced stage III non-small-cell lung cancer of other than predominantly squamous cell histology.

作者信息

Vokes Everett E, Senan Suresh, Treat Joseph A, Iscoe Neill A

机构信息

University of Chicago, IL, USA.

出版信息

Clin Lung Cancer. 2009 May;10(3):193-8. doi: 10.3816/CLC.2009.n.027.

Abstract

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.

摘要

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。

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