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Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer

NCT00639327 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-06-28

No results posted yet for this study

Summary

The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.

Conditions

Interventions

DRUG

S-1 + irinotecan

Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD

DRUG

irinotecan

Irinotecan 150mg/m2 iv on day one every two weeks until PD

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Japan Clinical Cancer Research Organization

    lead OTHER

Principal Investigators

  • Masashi Fujii, M.D.,PhD · Surugadai Nihon University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-04-30
Completion
2011-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00639327 on ClinicalTrials.gov