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Random Trial for Elderly Patients With NSCLC

A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00265694
Enrollment
Unknown
Registered
2005-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2005-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

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.

Interventions

DRUGvinorelbine, gemcitabine and carboplatin

Sponsors

Inje University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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)

Countries

South Korea

Contacts

Primary ContactYoung Jin Yuh, M.D.
yjyuh@sanggyepaik.ac.kr82-2-950-1460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026