NCT01131429Unknown2 期
Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Male and female patients aged over 18 years
- •Histologically proven lung adenocarcinoma
- •clinical stage IIIB/IV
- •ECOG performance status 0-2
- •Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma
- •At least one measurable lesion (according to RECIST)
- •Provision of written informed consent
- •Life expectancy of at least 12 weeks
排除标准
- •History of malignant disease.
- •Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- •Expected life expectancy less than 2 months
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- •Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- •Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
研究组 & 干预措施
first-line erlotinib
Experimental
erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment
干预措施: Erlotinib (Drug)
first-line erlotinib
Experimental
erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment
干预措施: Docetaxel (Drug)
first-line erlotinib
Experimental
erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment
干预措施: Cisplatin (Drug)
second-line erlotinib
Active Comparator
docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment
干预措施: Docetaxel (Drug)
second-line erlotinib
Active Comparator
docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment
干预措施: Cisplatin (Drug)
second-line erlotinib
Active Comparator
docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment
干预措施: Erlotinib (Drug)
结局指标
主要结局
Overall survival
时间窗: three year
次要结局
- progression-free survival during the first-line treatment(1 year)
- progression-free time during the second-line treatment(2 years)
- quality of life during the first-line therapy(every 3 weeks during first-line therapy)
- quality of life during the second-line therapy(every 3 weeks during the second-line therapy)
- response rates during the first-line treatment(at 6 months from treatment initiation)
- response rates during the second-line treatment(every 3 weeks during the treament, and and every 6 weeks thereafter)
- toxicity during the first-line treatment(at 12 months from treatment initiation)
- toxicity during the second-line treatment(end of study)
- preditive and prognostic markers for chemotherapy or erlotinib(end of study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use (CHINA RESOLUTE INTEGRITY STUDY)Ischemic Heart DiseaseCardiovascular DiseasesArteriosclerosisCoronary Artery DiseaseNCT02452736Medtronic Vascular205
已完成
不适用
A Study of Nivolumab in Participants With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology After Prior Chemotherapy Treated in Real World Settings in Greece and CyprusNon-Small Cell Lung CancerNCT05034926Bristol-Myers Squibb212
Unknown
不适用
Overall Survival and Disease-free Survival in Breast Cancer Patients Under COSBreast CancerNCT02745262IVI Vigo400
已完成
2 期
A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With AchondroplasiaAchondroplasiaNCT05246033Visen Pharmaceuticals (Shanghai) Co., Ltd.24
招募中
不适用
Establishment, Verification and Clinical Application of Chinese Version of Surgical Risk Assessment SystemRisk AssessmentRisk FactorsMachine LearningArtificial IntelligencePostoperative ComplicationsOperative Surgical ProcedureNCT05754268luyun10,000