Random Trial for Elderly Patients With NSCLC

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00265694
• Other study ID #: INJE05-06
• Status: Recruiting
• Phase: Phase 3
• First received: December 14, 2005
• Last updated: December 14, 2005

Study information

• Verified date: June 2005
• Source: Inje University
• Contact: Young Jin Yuh, M.D.
• Phone: 82-2-950-1460
• Email: yjyuh[@]sanggyepaik.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• vinorelbine, gemcitabine and carboplatin

Locations

Country	Name	City	State
Korea, Republic of	Inje University Sanggyepaik Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of,