Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study
There are two primary objectives in different steps. In the first step, the primary
objective of this study is to investigate the objective response rate in patients receiving
sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients
with unresectable gastric adenocarcinoma.
In the second step, the primary objective of this study is to screen the predictive
biomarkers of three different chemotherapeutic drugs and also investigate the objective
response rate in patients receiving sequential capecitabine plus oxaliplatin followed by
docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Tumor responses in measurable lesions are to be evaluated by the tumor response guidelines validated by the Response Evaluation Criteria in Solid Tumors (RECIST) Group . The new version 1.1 was published in 2009.
Every 6 weeks
Yes
Taiwan: Institutional Review Board
T3211
NCT01558011
March 2012
December 2016
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