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

Phase 3

Withdrawn

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: gemcitabine, cisplatin

• Registration Number: NCT00329472
• Lead Sponsor: Samsung Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-23
• Study First Posted: 2006-05-24
• Status Verified: 2010-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-08-26
• Last Update Posted: 2010-08-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gem/Cis	gemcitabine, cisplatin	neoadjuvant chemotherapy: gemcitabine 1250mg/m2 D1,D8 \& cisplatin 70mg/m2 , 2 cycles

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival

Secondary Outcome Measures

Name	Time	Method
overall survival
pattern of relapse
quality of life
operative mortality and toxicity