NCT00329472撤回3 期
Randomized Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Plus Adjuvant Chemotherapy Versus Surgery Plus Adjuvant Chemotherapy in Stage IB, IIA, IIB and T3N1 Non-small Cell Lung Cancer (ICON)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- 3-year disease-free survival
研究概览
简要总结
This study is randomized phase III trial designed to assess whether (preoperative) neoadjuvant chemotherapy followed by surgery plus adjuvant chemotherapy with gemcitabine and cisplatin (experimental treatment) improves 3-year disease-free survival, compared to surgery plus adjuvant chemotherapy with gemcitabine and cisplatin (standard treatment) in stage IB, IIA, IIB and T3N1 non-small cell lung cancer
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
- •Histologically or cytologically proven NSCLC patients
- •All patients must have:Clinical stage IB, IIA, IIB and T3N1 by mediastinoscopy, Chest CT and PET-CT
- •18 year of ages or older
- •ECOG performance status 0-1
- •Uni-dimensionally measurable lesion by RECIST criteria
- •No prior chemotherapy or radiotherapy for NSCLC
- •Pre-operative FEV1 ≥ 2.0 L evaluated within 28 days
- •Adequate bone marrow function: Hb > 9.0 g/dL, WBC ≥ 4,000/μL, platelet count ≥ 100,000/μL
- •Adequate liver and renal function: Total bilirubin < 2 x ULN, AST/ALT < 3 x ULN, serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min
- •Written informed consent
排除标准
- •Superior sulcus tumor
- •Prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer at least 5 years
- •Uncontrolled systemic illness such as DM, CHF, unstable angina or arrhythmia
- •Recent myocardial infarction within 6 months
- •Patients with post-obstructive pneumonia or serious infection
- •Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method.)
- •Patients with psychological problem
研究组 & 干预措施
Gem/Cis
Experimental
neoadjuvant chemotherapy: gemcitabine 1250mg/m2 D1,D8 & cisplatin 70mg/m2 , 2 cycles
干预措施: gemcitabine, cisplatin (Drug)
结局指标
主要结局
3-year disease-free survival
次要结局
- overall survival
- pattern of relapse
- quality of life
- operative mortality and toxicity
研究者
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