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Phase III clinical trials that integrate treatment and biomarker evaluation.

作者信息

Freidlin Boris, Sun Zhuoxin, Gray Robert, Korn Edward L

机构信息

National Cancer Institute, Bethesda, MD, USA.

出版信息

J Clin Oncol. 2013 Sep 1;31(25):3158-61. doi: 10.1200/JCO.2012.48.3826. Epub 2013 Apr 8.

DOI:10.1200/JCO.2012.48.3826
PMID:23569306
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3753704/
Abstract
摘要

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本文引用的文献

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Randomized phase II trial designs with biomarkers.随机化二期临床试验设计与生物标志物。
J Clin Oncol. 2012 Sep 10;30(26):3304-9. doi: 10.1200/JCO.2012.43.3946. Epub 2012 Aug 6.
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International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1.莫特塞尼布联合卡铂/紫杉醇治疗晚期非鳞状非小细胞肺癌的国际、随机、安慰剂对照、双盲 III 期研究：MONET1。
J Clin Oncol. 2012 Aug 10;30(23):2829-36. doi: 10.1200/JCO.2011.41.4987. Epub 2012 Jul 2.
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Testing in a Prespecified Subgroup and the Intent-to-Treat Population.在预先指定的亚组和意向性分析人群中进行测试。
Drug Inf J. 2012 Mar 1;46(2):175-179. doi: 10.1177/0092861512436579.
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Clinical trials for predictive medicine.预测医学的临床试验。
Stat Med. 2012 Nov 10;31(25):3031-40. doi: 10.1002/sim.5401. Epub 2012 Jun 19.
5
Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819.前瞻性生物标志物验证的 III 期临床试验设计：SWOG S0819。
Clin Cancer Res. 2012 Aug 1;18(15):4004-12. doi: 10.1158/1078-0432.CCR-12-0167. Epub 2012 May 16.
6
Prospective molecular marker analyses of EGFR and KRAS from a randomized, placebo-controlled study of erlotinib maintenance therapy in advanced non-small-cell lung cancer.一项随机、安慰剂对照的厄洛替尼维持治疗晚期非小细胞肺癌的前瞻性分子标志物分析：EGFR 和 KRAS。
J Clin Oncol. 2011 Nov 1;29(31):4113-20. doi: 10.1200/JCO.2010.31.8162. Epub 2011 Oct 3.
7
Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study.随机、III 期临床试验：帕尼单抗联合氟尿嘧啶、亚叶酸钙和奥沙利铂（FOLFOX4）对比 FOLFOX4 一线治疗未经治疗的转移性结直肠癌患者：PRIME 研究。
J Clin Oncol. 2010 Nov 1;28(31):4697-705. doi: 10.1200/JCO.2009.27.4860. Epub 2010 Oct 4.
8
Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer.一项比较帕尼单抗联合氟尿嘧啶、亚叶酸钙和伊立替康（FOLFIRI）与单独 FOLFIRI 二线治疗转移性结直肠癌患者的随机 III 期研究。
J Clin Oncol. 2010 Nov 1;28(31):4706-13. doi: 10.1200/JCO.2009.27.6055. Epub 2010 Oct 4.
9
Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study.厄洛替尼作为晚期非小细胞肺癌的维持治疗：一项多中心、随机、安慰剂对照的 3 期研究。
Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.
10
Randomized clinical trials with biomarkers: design issues.随机临床试验与生物标志物：设计问题。
J Natl Cancer Inst. 2010 Feb 3;102(3):152-60. doi: 10.1093/jnci/djp477. Epub 2010 Jan 14.