This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC
Docetaxel and gemcitabine 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. However, there are only few randomized trials evaluating a two drug combination specifically addressed to elderly patients. 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
106
Docetaxel at the dose of 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Gemcitabine at the dose of 900mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Gemcitabine at the dose of 1200mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
401 Military Hospital, Medical Oncology Unit
Athens, Greece
Overall survival between the two treatment arms
Time frame: Probability of 1 year survival (%)
Overall response rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Time to disease progression
Time frame: 1 year
Quality of life assessment
Time frame: Assessment every two cycles
Toxicity profile
Time frame: Assessment every two cycles
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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
Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
Athens, Greece
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Piraeus, Greece
Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki, Greece