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Random Trial for Elderly Patients With NSCLC
Conditions
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: vinorelbine, gemcitabine and carboplatin
Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 65 Years
Gender: Both
Criteria: 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)
- 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)
Location
Inje University Sanggyepaik Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Young Jin Yuh, M.D. - 82-2-950-1460 - yjyuh@sanggyepaik.ac.kr
Sponsors
Inje University
Source
Inje University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page