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Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer

Phase 2
Recruiting
Conditions
Gastric Cancer
Registration Number
JPRN-UMIN000012785
Lead Sponsor
Shimane University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma, and multicentric cancer. (2) Patients who are contraindicated to S-1, CDDP, and DTX. (3) Patient is taking flucytosine and phenytoin. (4) Patients with the history of severe drug hypersensitivity. (5) Patients with severe complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, severe diabetes, heart failure, renal failure, liver cirrhosis, liver failure, etc.). (6) Patients with diarrheal disease or watery diarrhea. (7) Pregnant and/or nursing women (8) Patients with positive HBs antigen (9) Any subject judged by the investigator to be unfit for any reason to participate in the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Treatment completion rate after 2 cycle of S-1, DTX plus CDDP
Secondary Outcome Measures
NameTimeMethod
Overall Survival, Relapse Free Survival, Completion rate of S-1 for 1year, Safety
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