NCT02399566Unknown4 期
Comparative Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma
Hunan Province Tumor Hospital0 个研究点目标入组 300 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The purpose of this study is to compare effects of erlotinib and pemetrexed as maintenance therapy for lung adenocarcinoma. Primary Outcome is the progression free survival (PFS). Based on prediction of different potential benefit groups, this study may help the oncologist to optimize and improve the maintenance therapy plan for lung adenocarcinoma.
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
- Double (Investigator, Outcomes Assessor)
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
- •Histologically or cytologically diagnosed stage III/IV Lung Adenocarcinoma;
- •Age of 18-75years; Gender Not Required;
- •Received systemic clinical examination, including chest X-ray, abdomen B ultrasound, head CT scan, radionuclide bone scan;
- •Received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is SD or above SD (efficacy evaluation time is 21 days, if it is SD, then the longest diameter of target lesions shall not increase);
- •Adequate hematologic, renal, and hepatic function, Specific index as follows: liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;
- •ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
- •The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);
- •No history of serious drug allergy;
- •Informed consent should be obtained before treatment.
排除标准
- •Not histologically or cytologically diagnosed as Lung Adenocarcinoma
- •The age of >75 years or <18 years.
- •Major organ dysfunction and Serious Heart Disease (congestive heart-failure, incontrollable high-risk arrhythmia, unstable angina, alular disease, myocardial infarct and Resistant hypertension,);
- •Serious complications and investigator consider it is unsuited enrolling;
- •Pregnant or lactating women;
- •Allergic to research drug;
- •Received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is PD
研究组 & 干预措施
Experimental
Experimental
followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy
干预措施: Erlotinib, Pemetrexed (Drug)
Comparator
Active Comparator
followed classical chemotherapy for 4 cycles, use Pemetrexed interventional for the maintenance therapy
干预措施: Erlotinib, Pemetrexed (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: two years
次要结局
- Objective response rate (ORR)(two years)
- The adverse reaction(two years)
- Time to progression (TTP)(two years)
- Overall survival (OS)(two years)
- Clinical benefit rate (CBR)(two years)
研究者
Jianhua Chen
MD
Hunan Province Tumor Hospital
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