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

Samsung Medical Center

Status and phase

Withdrawn

Phase 3

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: gemcitabine, cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00329472

2004-09-027

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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