The purpose of this study is to investigate the PFS, ORR, OS and overall toxicity value(OTV)on advanced adenocarcinoma treated with nedaplatin or cisplatin combined with pemetrexed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
293
cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 (Every three weeks for a treatment cycle)
nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 (Every three weeks for a treatment cycle)
Sun Yat-sen University of cancer center
Guangzhou, Guangdong, China
RECRUITINGprogression free-survival(PFS)
Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Time frame: 12months
objective response rate (ORR)
ORR is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).
Time frame: 12months
overall survival(OS)
OS is defined as the time from the starting date of study drug to the date of death due to any cause
Time frame: 24 months
overall toxicity value
toxicity graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0
Time frame: 12 months
Progression-Free Survival (PFS) rate at 18 weeks
the proportion (%) of patients without disease progression at 18 weeks
Time frame: 20 weeks
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