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

This study has been withdrawn prior to enrollment.
(poor enrollment)
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
First received: May 22, 2006
Last updated: August 26, 2010
Last verified: July 2010
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

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: gemcitabine, cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 3-year disease-free survival

Secondary Outcome Measures:
  • overall survival
  • pattern of relapse
  • quality of life
  • operative mortality and toxicity

Enrollment: 0
Study Start Date: April 2006
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gem/Cis
neoadjuvant chemotherapy: gemcitabine 1250mg/m2 D1,D8 & cisplatin 70mg/m2 , 2 cycles
Drug: gemcitabine, cisplatin
No Intervention: no neoadjuvant chemotherapy


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00329472

Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Keunchil Park, M.D. Samsung Medical Center
  More Information

Responsible Party: Keunchil Park/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00329472     History of Changes
Other Study ID Numbers: 2004-09-027 
Study First Received: May 22, 2006
Last Updated: August 26, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on May 02, 2016