The Study of Metastatic Pancreatic Adenocarcinoma

NCT01415713 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2016-05-04

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01415713 on ClinicalTrials.gov