1. Goals The primary goal of this phase II trial is to: evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as second-line treatment Secondary goals are to: evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population 2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Docetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks
Oxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
RECRUITINGChungbuk National University Hospital
Cheongju-si, South Korea
RECRUITINGChungnam National University Hospital
Daejeon, South Korea
RECRUITINGThe Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, South Korea
RECRUITINGChonbuk National University Hospital
Jeonju, South Korea
RECRUITINGResponse rate
Assessment of response will be assessed according to RECIST v1.1 criteria
Time frame: 2years
Overall survival
Overall survival will be calculated by Kaplan-Meier method
Time frame: 2years
Progression free survival
Progression free survival will be calculated by Kaplan-Meier method
Time frame: 2 years
Number of Participants with Adverse Events
Assessment of toxicity will be assessed according to CTCAE version 4.0
Time frame: 2 years
Quality of life
Quality of life will be assessed according to EORTC QLQ-C30, LC13
Time frame: 2 years
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