NCT00419042已完成不适用
A Multicenter Randomized Phase II Trial in NSCLC Stage IV et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progression.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 23
研究概览
简要总结
The purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first line followed by Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression
详细描述
A multicenter phase II trial,prospective,randomized,open,non comparative
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 65
- •Comorbidities score, PS and frailty score according to table 1
- •No dementia, faecal or urinary incontinence, repeated falls
- •ADL = 0, IADL = 0-1
- •Life expectancy at least 12 weeks
- •Creatinin clearance > = 30 ml/mn (according to Cockcrofts-Gault formula)
- •Competency to give written informed consent
- •Haematological functions as follows : neutrophiles count > 1.5 x 109/l and platelets > 100 x 109/l hemoglobin > 9,5 g/dl - Hepatic function as follows : Bilirubin < 1,25 LNS ASAT / ALAT <5 x NAlcPh <5 x N
- •cerebral metastasis eligible if asymptomatic
- •Histologically or cytologically confirmed NSCLC
- •Stage IV/IIIB4 (T4 with pleural effusion)
- •No prior chemotherapy
- •relapses of previous NSCLC treated by surgery or radiotherapy are eligible, if the target is measurable out of initial radiotherapy field and if cytological or histological proof
- •At least one measurable target lesion by RECIST guidelines
排除标准
- •symptomatic cerebral metastasis
- •Any severe comorbidity calculated by Charlson score according to table 1
- •ADL > 0 and IADL > 1- performance status >2 (ECOG)
- •peripheral neuropathy grade 2 or more
- •dementia, repeated falls, urinary or faecal incontinence
- •contra-indication to corticosteroids
- •contra indication to a product of this study
- •unwilling or unable to comply with study requirements, for personal, family, sociologic, geographic or any other reason
- •inability of the subject to give written informed consent
- •lack of liberty following legal or administrative decision
- •hypersensitivity to polysorbate
- •hypersensitivity to erlotinib or any excipients of this product
- •unusual hereditary disorders, as galactosemia, deficit in lactase and syndrome of malabsorption in glucose or galactose
- •participation in concomitant clinical trial
- •bronchioloalveolar or neuroendocrine or composite carcinoma
- •superior vena cava syndrome
研究者
研究点 (23)
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