Randomized Phase II Study Evaluating The Tolerability Of Adjuvant Docetaxel-based Chemotherapy For Completely Resected Stage IB-II Non-Small Cell Lung Cancer (NSCLC): Toledo Trial

University Hospital, Antwerp6 个研究点分布在 1 个国家目标入组 99 人开始时间: 2005年12月最近更新: 2010年11月30日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: University Hospital, Antwerp
入组人数: 99
试验地点: 6
主要终点: Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•completely resected pathological stage IB or II NSCLC
•adequate haematological, renal and liver function and condition

排除标准

•previous chemo or radiotherapy for NSCLC
•bronchoalveolar cell subtype
•second active primary malignancy or serious concomitant medical disease
•difficulties with adequate follow-up

结局指标

主要结局

Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle

Success of delivery treatment; data collected during chemotherapy treatment

次要结局

Overall toxicity
Progression free survival and overall survival

研究者

发起方

University Hospital, Antwerp

申办方类型

Other

研究点 (6)

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