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Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer

Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer - Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000117
Enrollment
180
Registered
2005-09-06
Start date
2000-05-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

elderly patients with advanced non-small cell lung cancer

Interventions

docetaxel 60 mg/m2 on day 1,repeated every 21 days over four cycles vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles.

Sponsors

West Japan Oncology Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Chemotherapy- and radiotherapy-naïve patients with histologically or cytologically diagnosis of stage IIIB or IV NSCLC and who were over 70 years old with measurable or assessable disease were eligible for this trial.They had to have a life expectancy of at least 3 months.Additional entry criteria were as follows:(a) a performance status (PS) 0 to 2 on the Eastern Cooperative Oncology Group scale;(b) adequate function of bone marrow , kidney , liver .

Exclusion criteria

Exclusion criteria: Patients with symptomatic brain metastasis or apparent dementia were ineligible. Patients with active concomitant malignancy, massive pleural effusion or asites, active infection, severe heart disease, grade 2 or higher ECG abnormality, uncontrolled diabetes mellitus, ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded.

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
safety,efficacy,QOL

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026