This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC.
Docetaxel and vinorelbine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
University General Hospital of Alexandroupolis, Department of Medical Oncology
Alexandroupoli, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
Overall survival between the two treatment arms
Time frame: 1 year
Time to disease progression
Time frame: 1 year
Toxicity profile
Time frame: During the time of chemotherapy
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IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens, Greece
Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
Athens, Greece
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
Athens, Greece
Sotiria General Hospital, 1st, 3rd, 8th Department of Pulmonary Diseases
Athens, Greece
State General Hospital of Larissa, Department of Medical Oncology
Larissa, Greece
Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
Piraeus, Greece
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki, Greece