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. 2017 Aug 29;2017(8):CD004064. doi: 10.1002/14651858.CD004064.pub4

NCT02583659.

Trial name or title The first‐line combined chemotherapy for advanced gastric cancer: A prospective observational clinical study
Methods Observational Model: Cohort
Time Perspective: Prospective
Participants N = 250
Histopathology or cytopathology confirmed unresectable locally advanced, or recurrent, or metastatic chemotherapy‐naive gastric cancer and gastroesophageal adenocarcinoma participants
Interventions Observational Model: Cohort
Time Perspective: Prospective
Outcomes Overall survival (OS) [Time frame: From date of enrolment until the date of death from any cause, assessed up to 60 months]
Progression‐free survival (PFS) [Time frame: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
Objective response rate (ORR) [Time frame: The sum of complete remission (CR) rate and partial remission (PR) rate. Response will be measured through first‐line treatment completion, up to 1 year]
Disease control rate (DCR) [Time frame: The sum of CR rate, PR rate and stable disease (SD) rate. Response will be measured through first‐line treatment completion, up to 1 year]
Number of participants with treatment‐related adverse events as assessed by CTCAE v4.0 [Time frame: Through first‐line treatment completion, up to 24 weeks.]
Starting date January 2013
Contact information Xianglin Yuan, MD,PHD
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
Notes