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

This study has been withdrawn prior to enrollment.
(poor enrollment)
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00329472
First received: May 22, 2006
Last updated: August 26, 2010
Last verified: July 2010
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014