Spots Global Cancer Trial Database for Docetaxel and Epirubicin in Advanced Gastric Cancer
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Trial Identification
Brief Title: Docetaxel and Epirubicin in Advanced Gastric Cancer
Official Title: A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.
Study ID: NCT00375999
Conditions
Interventions
Study Description
Brief Summary: 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yongdong Severance Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Jae Yong Cho
Affiliation: Yonsei University
Role: PRINCIPAL_INVESTIGATOR
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