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Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Advanced Gastric Carcinoma

NCT00503321 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2009-01-23

No results posted yet for this study

Summary

A randomized controlled study is conducted on unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1 + PSK therapy. The primary endpoint of this study is progression-free survival (PFS), with secondary endpoints of anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors.

Conditions

Interventions

DRUG

Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)

S-1 80mg/m2 4weeks on 2 weeks off, PSK 3g/day

DRUG

Tegafur/gimeracil/oteracil potassium (S-1)

S-1 80mg/m2, 4weeks on followed by 2 weks off

Sponsors & Collaborators

  • Eastern Network of Cancer Immunological Therapy, Japan

    lead OTHER

Principal Investigators

  • Hideaki Tahara, MD · Eastern Network of Cancer Immunological Therapy, Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-08-31
Completion
2011-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT00503321 on ClinicalTrials.gov