Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients

NCT00687843 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2012-03-22

No results posted yet for this study

Summary

Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.

Conditions

Interventions

DRUG

Tegafur-gimeracil-oteracil potassium (TS-1)

80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8

DRUG

Krestin (PSK)

3 g, PO from day 1 to day 336

Sponsors & Collaborators

  • Tokyo Metropolitan Oncology Group

    lead OTHER

Principal Investigators

  • Masatsugu Kitamura, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2016-03-31
Completion
2016-03-31

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 NCT00687843 on ClinicalTrials.gov