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

NCT00441740 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2008-10-31

No results posted yet for this study

Summary

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Vinorelbine

Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles

DRUG

Gemcitabine

Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

DRUG

Docetaxel

Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • Vassilis Georgoulias, MD · University Hospital of Crete, Dep of Medical Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00441740 on ClinicalTrials.gov