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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00329472 |
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Date of registration:
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22/05/2006 |
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Primary sponsor: |
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Public title:
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Efficacy Study of Induction Chemotherapy Before Surgery in Operable Non-small Cell Lung Cancer
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Scientific title:
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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) |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00329472 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Keunchil Park, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Samsung Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma, Non-Small-Cell Lung
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Intervention(s)
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Drug: gemcitabine, cisplatin
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Primary Outcome(s)
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3-year disease-free survival
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Secondary Outcome(s)
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operative mortality and toxicity
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overall survival
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pattern of relapse
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quality of life
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Secondary ID(s)
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2004-09-027
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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