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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
gemcitabine, cisplatin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Gem/Cis

    no neoadjuvant chemotherapy

    Arm Description

    neoadjuvant chemotherapy: gemcitabine 1250mg/m2 D1,D8 & cisplatin 70mg/m2 , 2 cycles

    Outcomes

    Primary Outcome Measures

    3-year disease-free survival

    Secondary Outcome Measures

    overall survival
    pattern of relapse
    quality of life
    operative mortality and toxicity

    Full Information

    First Posted
    May 22, 2006
    Last Updated
    August 26, 2010
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00329472
    Brief Title
    Efficacy Study of Induction Chemotherapy Before Surgery in Operable Non-small Cell Lung Cancer
    Official Title
    Randomized Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Plus Adjuvant Chemotherapy Versus Surgery Plus Adjuvant Chemotherapy in Stage IB, IIA, IIB and T3N1 Non-small Cell Lung Cancer (ICON)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    poor enrollment
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    July 2010 (Anticipated)
    Study Completion Date
    July 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    5. Study Description

    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 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Non-Small-Cell Lung

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gem/Cis
    Arm Type
    Experimental
    Arm Description
    neoadjuvant chemotherapy: gemcitabine 1250mg/m2 D1,D8 & cisplatin 70mg/m2 , 2 cycles
    Arm Title
    no neoadjuvant chemotherapy
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    gemcitabine, cisplatin
    Primary Outcome Measure Information:
    Title
    3-year disease-free survival
    Secondary Outcome Measure Information:
    Title
    overall survival
    Title
    pattern of relapse
    Title
    quality of life
    Title
    operative mortality and toxicity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keunchil Park, M.D.
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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