Stomach Neoplasms Clinical Trial
Official title:
A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.
1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric
cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic
chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the
Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response
3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1
as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks.
4.Primary endpoints:
1. Efficacy:overall response rate according to the Response Evaluation Criteria in Solid
Tumors criteria, time to response, duration of response, and time to treatment failure.
2. Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity
Criteria for Adverse Effects (version 3.0).
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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