Status:
WITHDRAWN
Efficacy Study of Induction Chemotherapy Before Surgery in Operable Non-small Cell Lung Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00329472
Start Date
April 1 2006
End Date
July 1 2010
Last Update
August 27 2010
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