NCT00418704已完成不适用
A Multicenter Randomized Phase II Trial in NSCLC Stage IV and IIIB (T4 With Pleural Effusion) in Elderly Independent Patients the Schedule Docetaxel / Gemcitabine First Line Following by Erlotinib When Progression Versus Erlotinib First Line Following 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
- 22
研究概览
简要总结
The purpose of this study is to determine duration before progression of first-line treatment chemotherapy following erlotinib in second-line comparing erlotinib in first-line following chemotherapy in second-line in old patients with none small cell lung cancer.
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 years
- •Comorbidities score,
- •PS frailty score**.according to(TABLE N°1)
- •No dementia, repeated falls, faecal or urinary incontinence, ADL=0, IADL=0
- •Life expectancy at least 12 weeks
- •Créatinine clearance de la créatinine > or =30cc/mn according to Cockrofts
- •Gault formula
- •Competency to give written informed consent
- •Haematological function as follows: absolute neutrophil count > 1.5 x 109/l and/or platelet> 100 x 109/l, hémoglobine > or = 9,5 g/dl
- •Hepatic function as followed :bilirubin <1,25 LNS SGOT/SGPT <5 x N,PAL <5N
- •No symptomatic cerebral metastasis
- •Histologically or cytologically confirmed NSCLC
- •Stage IV/IIIB4 (T4with pleural effusion)
- •No prior chemotherapy for NSCLC
- •Relapses of previous NSCLC treated by surgery or radiotherapy are eligible if the target is measurable out of initial radiotherapy field and if histological or cytological proof
- •At least one measurable target lesion by RECIST guidelines.
排除标准
- •Symptomatic cerebral metastasis
- •Any severe co-morbidity calculated by Charlson score (according to table 1), any kind of disorder that compromises the ability of the subject to give written informed and/or comply with the study procedure ADL > or = 1 et IADL > or =1 Dementia, repeated falls, faecal or urinary incontinence- Peripheral neuropathy grade 2 or more
- •Performance Status > 2 ( ECOG)- Contraindication to corticosteroids
- •Unwilling or unable to comply with study requirements for personal , family, sociologic, geographic or any reasons
- •Lack of liberty following administrative or judicial decision
- •Hypersensitivity to polysorbate
- •Hypersensitivity to erlotinib or any excipients of this product
- •Unusual hereditary disorders as galactosemia, deficit in lactase and malabsorption in glucose or galactose
- •Participation in concomitant clinical trial
- •Contraindication to a product of this study disease
- •Bronchioloalvéolar or neuroendocrine or composite carcinoma
- •Superior vena cava syndrome
研究者
研究点 (22)
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