GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

NCT00514163 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2011-06-28

No results posted yet for this study

Summary

The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer

Conditions

Interventions

DRUG

gemcitabine + S-1

gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks

DRUG

gemcitabine

gemcitabine DIV on day one , 8th and 15th

Sponsors & Collaborators

  • Japan Clinical Cancer Research Organization

    lead OTHER

Principal Investigators

  • Takaaki Ikari, MD. PhD · Cancer Institute Ariake Hospital

  • Masafumi Suyama, M.D. PhD · Juntenndo University Hospital

  • Naoto Egawa, M.D. PhD · Komagome Hospital

  • Yasuji Omuro, M.D. PhD · Komagome Hospital

  • Takao Itoi, M.D. PhD · Tokyo Medical college

  • Atsushi Sofuni, M.D. PhD · Tokyo medical college

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-08-31
Completion
2010-12-31

Countries

  • Japan

Study Locations

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Entities

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 NCT00514163 on ClinicalTrials.gov