Non Small Cell Lung Cancer Clinical Trial
Official title:
Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial
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.
Status | Completed |
Enrollment | 419 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC - No previous therapy for advanced/metastatic NSCLC is allowed - Age > 18 years - Bidimensionally measurable disease - Performance status (WHO) 0-2 - Adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT < 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the UNL); and bone marrow (neutrophils = 1.5x 109 /L, and platelets = 100x 109 /L) function - Previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields - Life expectancy of more than 3 months - Patient able to take oral medication - At least 4 weeks since prior radiotherapy - Written informed consent Exclusion Criteria: - Active infection - History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) - Malnutrition (loss of = 20% of the original body weight) - Performance status: 3-4 - Sensor or motor neuropathy > grade I - Second primary malignancy, except for non-melanoma skin cancer - Psychiatric illness or social situation that would preclude study compliance - Pregnant or lactating women - Known, symptomatic central nervous system metastases |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | University General Hospital of Alexandroupolis, Dep of Medical Oncology | Alexandroupolis | |
Greece | " General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases | Athens | |
Greece | "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Athens | |
Greece | "Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology | Athens | |
Greece | 401 Military Hospital, Medical Oncology Unit | Athens | |
Greece | Air Forces Military Hospital, Dep of Medical Oncology | Athens | |
Greece | IASO" General Hospital of Athens, 1st Dep of Medical Oncology | Athens | |
Greece | Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases | Athens | |
Greece | "Theagenion" Anticancer Hospital of Thessaloniki | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Hellenic Oncology Research Group | University Hospital of Crete |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | 1 year | No | |
Secondary | Response rate | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | No | |
Secondary | Time to tumor progression | 1 year | No | |
Secondary | Toxicity | Toxicity assessment on each chemotherapy cycle | Yes | |
Secondary | Quality of life | Assessment every two cycles | No |
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