CTRI/2014/09/005041招募中4 期
Comparative study evaluating Quality Of Life of chemotherapy versus Oral TKI in third line and beyond Setting for advanced non-small cell lung cancer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Inclusion criteria :
- •TKI-naive patients with documented stage IIIB ( treated with palliative intent) or stage IV NSCLC who have progressed on first and second line chemotherapy regimens
- •.2. ECOG Performance status (PS) from 0 to 2
- •3. Age >= 18yrs
- •4. Adequate bone marrow tests (absolute neutrophil count >1500/lL, hemoglobin > 8 g/dL, and platelet count >100,000/lL), renal function tests (creatinine <2 mg/dL), and liver function tests (total bilirubin <1.5 times the institutional upper limit of normal [ULN], aspartate aminotransferase and alanine aminotransferase levels <2 times the institutional ULN);
- •5. Life expectancy >= 3 months
- •6. Clinically stable brain metastases if any
排除标准
- •1.Prior therapy with TKI
- •2.Patients with EGFR mutation
- •3. A second primary tumor
- •4. Uncontrolled infection
- •5.Uncontrolled co-morbidities
研究者
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