Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer

NCT00287768 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 628

Last updated 2011-06-28

No results posted yet for this study

Summary

The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.

Conditions

Interventions

DRUG

docetaxel + S-1

Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks

DRUG

S-1

S-1 po days 1-28 every 6 weeks

Sponsors & Collaborators

  • Korean Cancer Study Group

    collaborator OTHER
  • Japan Clinical Cancer Research Organization

    lead OTHER

Principal Investigators

  • Masashi Fujii, MD PhD · Surugadai Nihon University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-09-30
Completion
2010-10-31

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 NCT00287768 on ClinicalTrials.gov