Status:
UNKNOWN
Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givin...
Detailed Description
OBJECTIVES: Primary * Compare the time to recurrence in patients with stage IB or II non-small cell lung cancer treated with neoadjuvant versus adjuvant gemcitabine hydrochloride and cisplatin. Sec...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Squamous cell or nonsquamous cell histology
- Stage IB or II disease
- Tumor amenable to curative surgical resection
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- Medical fitness must be adequate for radical NSCLC surgery
- WBC ≥ 4,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Bilirubin normal
- ALT and AST ≤ 2.5 times upper limit of normal
- Creatinine ≤ 1.5 mg/dL
- No second primary malignancy
- No active uncontrolled infection
- No concurrent serious disorder that would compromise patient safety or tolerance of study therapy
- No significant neurological or mental disorder
- No myocardial infarction within the past 6 months
- No symptomatic heart disease, including any of the following:
- Unstable angina
- Congestive heart failure
- Uncontrolled arrhythmia
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or anticancer therapy
- No prior surgery for NSCLC
- No prior or concurrent radiotherapy or immunotherapy (e.g., biologic response modifier)
- No major surgery (other than biopsy) within the past 2 weeks
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00398385
Start Date
May 1 2005
Last Update
August 12 2013
Active Locations (1)
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1
National Cancer Center - Korea
Goyang, South Korea, 410-769