NCT01282151终止3 期
A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 148
- 试验地点
- 15
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study is:
- A multicenter, prospective, randomized, phase 3 trial.
- To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer.
- 276 patients will be recruited.
详细描述
Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years old
- •ECOG performance status 0-2
- •Non-squamous cell type non-small cell lung cancer (NSCLC)
- •Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery or radiation therapy
- •No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.
- •No prior immunotherapy, biologic therapy
- •Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •Hemoglobin >=9.0g/dl, Platelet >=100,000/uL, neutrophil >=1,500 /uL Creatinine <=1.5 x upper normal limit or creatinine clearance >=60 mL/min Bilirubin <=1.5 x upper normal limit, Transaminases <=2 x upper normal limit Alkaline phosphatase <=2 x upper normal limit
- •Written informed consent
排除标准
- •Pregnancy, Lactating woman
- •Woman in child bearing age who refuses to do pregnancy test
- •Moderate or greater than grade 1 motor or sensory neurotoxicity
- •Hypersensitivity to taxane
- •Comorbidity or poor medical conditions
- •Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ)
- •Concurrent treatment with other investigational drugs within 30 days before randomization
- •Active treatment with other anticancer chemotherapy
- •EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)
研究组 & 干预措施
Taxotere
Experimental
Docetaxel plus Cisplatin
干预措施: Taxotere (Drug)
Pemetrexed
Active Comparator
Pemetrexed plus Cisplatin
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: one year
months after beginning of first cycle chemotherapy
次要结局
- Overall Survival (months from the beginning of first cycle chemotherapy)(three years)
- Safety Profile(four months)
- Response rate(6-7th week)
研究者
Young-Chul Kim
Professor
Chonnam National University Hospital
研究点 (15)
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