The Study of Metastatic Pancreatic Adenocarcinoma
NCT01415713 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2016-05-04
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
Conditions
- Metastatic Pancreatic Adenocarcinoma
Interventions
- DRUG
-
S-1,Leucovorin,Oxaliplatin,Gemcitabine
Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma
Sponsors & Collaborators
-
National Taiwan University Hospital
collaborator OTHER -
National Cheng-Kung University Hospital
collaborator OTHER -
Chang Gung Memorial Hospital
collaborator OTHER -
National Health Research Institutes, Taiwan
lead OTHER
Principal Investigators
-
Li-Tzong Chen, Ph.D. · National Institute of Cancer Research
-
Kelvin Kun-Chih Tsai, Ph.D. · National Institute of Cancer Research
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-03-31
- Primary Completion
- 2016-04-30
- Completion
- 2016-04-30
Countries
- Taiwan
Study Locations
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