NCT00329472
Withdrawn
Phase 3
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)
ConditionsCarcinoma, Non-Small-Cell Lung
Interventionsgemcitabine, cisplatin
Overview
- Phase
- Phase 3
- Intervention
- gemcitabine, cisplatin
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Samsung Medical Center
- Primary Endpoint
- 3-year disease-free survival
- Status
- Withdrawn
- Last Updated
- 15 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Gem/Cis
neoadjuvant chemotherapy: gemcitabine 1250mg/m2 D1,D8 \& cisplatin 70mg/m2 , 2 cycles
Intervention: gemcitabine, cisplatin
Outcomes
Primary Outcomes
3-year disease-free survival
Secondary Outcomes
- overall survival
- pattern of relapse
- quality of life
- operative mortality and toxicity
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