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

• Status: Withdrawn
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Cisplatin; Gemcitabine

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