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

NCT00329472 | Withdrawn Phase 3

• 1 other identifier: 2004-09-027
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival

Secondary Outcomes (4)

• overall survival

• pattern of relapse

• quality of life

• operative mortality and toxicity

Study Arms (2)

Gem/Cis

EXPERIMENTAL

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

Drug: gemcitabine, cisplatin

no neoadjuvant chemotherapy

NO INTERVENTION

Interventions

gemcitabine, cisplatin DRUG

Gem/Cis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven NSCLC patients
• All patients must have:Clinical stage IB, IIA, IIB and T3N1 by mediastinoscopy, Chest CT and PET-CT
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Keunchil Park, M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2006
• First Posted: May 24, 2006
• Study Start: April 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 27, 2010

Record last verified: 2010-07