This study is: * A multicenter, prospective, randomized, phase 3 trial. * To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer. * 276 patients will be recruited.
Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Kyungpook National University Medical Center
Daegu, Kyungpook, South Korea
Hallym University Medical Center
Anyang, South Korea
Progression Free Survival
months after beginning of first cycle chemotherapy
Time frame: one year
Overall Survival (months from the beginning of first cycle chemotherapy)
months from the beginning of first cycle chemotherapy
Time frame: three years
Safety Profile
Toxicity using CTCAE version 4.0
Time frame: four months
Response rate
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: 6-7th week
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Dankook University Hospital
Cheonan, South Korea
Keimyung University Dongsan Center
Daegu, South Korea
Yeungnam Univeristy Hospital
Daegu, South Korea
Chosun University Hospital
Gwangju, South Korea
Wonkwang University Hospital
Iksan, South Korea
Inha University Hospital
Incheon, South Korea
Pusan National University Hospital
Pusan, South Korea
...and 5 more locations