Random Trial for Elderly Patients With NSCLC

Inje University

Status and phase: Unknown; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: vinorelbine, gemcitabine and carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00265694

INJE05-06

Details and patient eligibility

About

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.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)