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 |
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