Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Erlotinib 150 mg/d per os until proven disease progression
Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment
cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment
Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
Erlotinib 150 mg/d per os as second-line treatment
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Overall survival
Time frame: three year
progression-free survival during the first-line treatment
Time frame: 1 year
progression-free time during the second-line treatment
Time frame: 2 years
quality of life during the first-line therapy
Time frame: every 3 weeks during first-line therapy
quality of life during the second-line therapy
Time frame: every 3 weeks during the second-line therapy
response rates during the first-line treatment
Time frame: at 6 months from treatment initiation
response rates during the second-line treatment
Time frame: every 3 weeks during the treament, and and every 6 weeks thereafter
toxicity during the first-line treatment
Time frame: at 12 months from treatment initiation
toxicity during the second-line treatment
Time frame: end of study
preditive and prognostic markers for chemotherapy or erlotinib
tissues for markers analysis are acquired during diagnosis procedure with informed consent.
Time frame: end of study
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