Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00441740
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles
  • Gemcitabine — DRUG
    Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
  • Docetaxel — DRUG
    Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles

Study Details

The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC.

Key Dates

Start date
Apr 30, 2004
Status verified
Oct 2008
Primary completion
Feb 29, 2008
Completion
Feb 29, 2008

Study Design

Enrollment
419 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    VG
  • Experimental: 2
    DG

Primary Outcome Measure

Overall survival [ Time Frame: 1 year ]

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