Spots Global Cancer Trial Database for The Study of Metastatic Pancreatic Adenocarcinoma
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Trial Identification
Brief Title: The Study of Metastatic Pancreatic Adenocarcinoma
Official Title: Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma
Study ID: NCT01415713
Conditions
Interventions
Study Description
Brief Summary: Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study
Detailed Description: Phase I: 2\~24 patients Phase II: Considering a design with p0 = 0.25 and p1 = 0.40 for which error is 0.10 and errors is 0.20, these constraints can be met with a two-stage Simon's design of 25 patients in the first stage and 27 patients in the second stage.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Taiwan University Hospital, Taipei, , Taiwan
Contact Details
Name: Li-Tzong Chen, Ph.D.
Affiliation: National Institute of Cancer Research
Role: STUDY_CHAIR
Name: Kelvin Kun-Chih Tsai, Ph.D.
Affiliation: National Institute of Cancer Research
Role: PRINCIPAL_INVESTIGATOR
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