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

Last updated: August 26, 2010
Sponsor: Samsung Medical Center
Overall Status: Trial Not Available

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00329472
2004-09-027
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically proven NSCLC patients

  • All patients must have:Clinical stage IB, IIA, IIB and T3N1 by mediastinoscopy, ChestCT 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, serumcreatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Superior sulcus tumor

  • Prior malignancy except for adequately treated basal cell or squamous cell skin canceror 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 aneffective contraceptive method.)

  • Patients with psychological problem

Study Design

Study Start date:
April 01, 2006
Estimated Completion Date:
July 31, 2010