Status:
COMPLETED
Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer
Lead Sponsor:
Hamamatsu University
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
76+ years
Phase:
PHASE2
Brief Summary
A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly gemcitabine in elder patients (\> 75) with previously untreated advanced non-small cell lung cancer. Primar...
Eligibility Criteria
Inclusion
- Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
- Good performance status (ECOG 0-1)
- No previous treatment
- Age 76 years and older
- Adequate bone marrow, liver and renal functions
- No pregnant
- Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as \>=1.0 cm by spiral CT scan
- Provided written informed consent
Exclusion
- Severe complications or a concomitant malignancy
- Prior and other concurrent radiotherapy, chemotherapy, immunotherapy, EGFR tyrosine kinase inhibitors
- Interstitial pneumonia or lung fibrosis
- Contraindicated gemcitabine or carboplatin
- Inappropriate patients for entry to this study, judged by the physicians
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00881296
Start Date
March 1 2008
End Date
June 1 2011
Last Update
September 7 2011
Active Locations (1)
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1
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan, 431-3192