Random Trial for Elderly Patients With NSCLC
Phase 3
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT00265694
- Lead Sponsor
- Inje University
- Brief Summary
1. Recently a radomized trial of vinorelbine versus best supportive care in patients at 70 years of age or older demonstrated a definite improvement in overall survival rate and quality of life with chemotherapy.
2. The role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague.
3. Gemcitabine and carboplatin have favorable toxicity profile.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients with pathologically confirmed, advanced(clinical stage IIIB or IV) NSCLC
- No previous chemotherapy history
- Age ≥ 65 years
- ECOG performance status ≤ 2
- Adequate marrow function (ANC ≥ 2,000/mm3, platelet ≥ 100,000/mm3), renal and liver function (total bilirubin < 2.0 mg/dL, AST/ALT levels < 3 × the upper limit of normal, serum creatinine < 2.0 mg/dL)
- Patients with informed written consent
Exclusion Criteria
- Patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Inje University Sanggyepaik Hospital
🇰🇷Seoul, Korea, Republic of