Efficacy Study of Induction Chemotherapy Before Surgery in Operable Non-small Cell Lung Cancer
NCT ID: NCT00329472
Last Updated: 2010-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2006-04-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gem/Cis
neoadjuvant chemotherapy: gemcitabine 1250mg/m2 D1,D8 \& cisplatin 70mg/m2 , 2 cycles
gemcitabine, cisplatin
no neoadjuvant chemotherapy
No interventions assigned to this group
Interventions
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gemcitabine, cisplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Samsung Medical Center
Principal Investigators
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Keunchil Park, M.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Other Identifiers
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2004-09-027
Identifier Type: -
Identifier Source: org_study_id
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