临床试验/NCT01466244

NCT01466244已完成不适用

PTEN Determination in Squamous Cell Cancer of The Head and Neck Treated on E5397, A Randomized Phase III Trial of Cisplatin Plus Placebo Versus Cisplatin Plus C225 (Cetuximab) in Metastatic/Recurrent Head and Neck Cancer

Eastern Cooperative Oncology Group0 个研究点目标入组 42 人开始时间: 2011年11月11日最近更新: 2017年5月17日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Eastern Cooperative Oncology Group
入组人数: 42
主要终点: Cetuximab activity as reflected in RR

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with metastatic or recurrent head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.

详细描述

OBJECTIVES:

Primary

Compare cetuximab activity, as reflected in response rate (RR), in PTEN-deficient and PTEN-expressing cancers.

Secondary

Examine RR, progression-free survival (PFS), and overall survival (OS) in PTEN-deficient and PTEN-expressing cancers, by treatment arm.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Retrospective

入排标准

年龄范围: 18 Years 至 120 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Cetuximab activity as reflected in RR

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方

Eastern Cooperative Oncology Group

申办方类型

Network

责任方

Sponsor

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