Nedaplatin (Jiebaishu®) and Docetaxel in Comparison With Cisplatin and Docetaxel Regimen for the First Line Treatment of Advanced Squamous Cell Carcinoma of Lung(IIIB/IV): Randomized, Controlled, Multicentre Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 4
- 主要终点
- progress free survival
研究概览
简要总结
The treatment of squamous cell carcinoma of lung has not improved suffuciently. Nedaplatin is a second-generation platinum compound that is more active against squamous cell carcinoma of the lung with a response rate of 60%, issued by the finished Phase II trial in Japan.
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
- •primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
- •IIIB-no radiotherapy indication /IV phased by ASLC 2009 TNM criteria.
- •at least one measurable tumor based on RECIST ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT )
- •male or female, age≥18 or ≤75 years old
- •ECOG PS: 0 or 1
- •estimated time of survival: ≥12 weeks
- •suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL
- •suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN.
- •suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min
- •no history of chemotherapy
- •at the enrollment, the past operation has been over 4 weeks and the subject recovered.
- •for the female subject with the intact uterus, if amenorrhea is less than 24 months, pregnancy test must be negative within 28 days of enrollment. If pregnancy test has been past 7 days at the time of initial chemotherapy, urine pregnancy test must be done.
- •the authorized ICF must be signed
排除标准
- •having the other cancer in the recent five years, cured skin basal cell carcinoma and cervical carcinoma excluded.
- •having the evidence of CNS metastasis, no matter if treated; if being suspicious of CNS metastasis, CNS MRI or enhanced CT scan must be done within 28 days of enrollment.
- •AST and /or ALT>2.5×normal ULN, and ALP>5×normal ULN.
- •radiotherapy in the past (excluding palliative radiotherapy for pain relief and the measurable tumor outside the radio field)
- •chemotherapy in the past (excluding bisphosphonates )
- •having the other uncontrolled diseases.
- •the female in pregnancy or feeding.
- •the subjects with the productivity capacity, but refusal to use the effective contraception measure.
- •participating in other clinical trial and at the time of treatment period.
- •allergy to the tested drugs
- •having the other uncontrolled diseases
- •BMT had been done.
研究组 & 干预措施
experimental group
experimental group: Nedaplatin(（80 mg/m2, i.v Day1）in combination with Docetaxel（75 mg/m2, i.v Day1）for each cycle, 4 cycles in total.
干预措施: Nedaplatin (Drug)
experimental group
experimental group: Nedaplatin(（80 mg/m2, i.v Day1）in combination with Docetaxel（75 mg/m2, i.v Day1）for each cycle, 4 cycles in total.
干预措施: Docetaxel (Drug)
comparative group
comparative group:Cisplatin (（75 mg/m2, i.v Day1 or 25 mg/m2 Day1-3）in combination with Docetaxel（75 mg/m2, i.v Day1）for each cycle, 4 cycles in total
干预措施: Cisplatin (Drug)
comparative group
comparative group:Cisplatin (（75 mg/m2, i.v Day1 or 25 mg/m2 Day1-3）in combination with Docetaxel（75 mg/m2, i.v Day1）for each cycle, 4 cycles in total
干预措施: Docetaxel (Drug)
结局指标
主要结局
progress free survival
时间窗: 9 months
after being enrolled, the subjects will be subject to 4 cycles chemotherapy (each cycle: 21 days). if complete response/partial response/stable desease is confirmed, the subjects will be followed up till to the sixth months.
次要结局
- Objective Response Rate(3 months)