Efficacy Study of Induction Chemotherapy Before Surgery in Operable Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: gemcitabine, cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gem/Cis<br>neoadjuvant chemotherapy: gemcitabine 1250mg/m2 D1,D8 & cisplatin 70mg/m2 , 2 cycles | Drug: gemcitabine, cisplatin<br> <br> |
| No Intervention: no neoadjuvant chemotherapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 
| pattern of relapse |  |  | 
| quality of life |  |  | 
| operative mortality and toxicity |  |  |