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Multicenter phase II study of combination therapy with oral S-1 plus cisplatin in elderly patients with metastatic gastric cancer

Phase 2
Conditions
Elderly patients with metastatic gastric cancer
Registration Number
JPRN-UMIN000009349
Lead Sponsor
ational Cancer Center Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 2) Body temperature >= 38C 3) Severe mental disease 4) Current treatment with systemic steroids 5) Uncontrolled diabetes mellitus 6) Unstable angina pectoris within the past 3 weeks, or previous myocardial infarction within the past 6 months 7) Evidence of any other serious disease; renal failure, hepatic failure, interstitial pneumonia, or pulmonary fibrosis 8) Active bleeding 9) Massive ascites 10) Massive pleural effusion 11) Judged ineligible by the clinical investigators

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall survival
Secondary Outcome Measures
NameTimeMethod
Response rate, progression-free survival, time to treatment failure, adverse events
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