Overview

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Withdrawn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