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Phase 2 study of alternate-day administrations of S-1 in elderly patients with advanced/recurrent gastric cancer (KDOG 1301)

Phase 2
Conditions
Advanced or recurrent gastric cancer
Registration Number
JPRN-UMIN000013019
Lead Sponsor
Department of Gastroenterology, Kitasato University School of Medicine
Brief Summary

Clinical trial discontinued due to sluggish accumulation of 6 registered cases

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
6
Inclusion Criteria

Not provided

Exclusion Criteria

1. History of hypersensitivity for S-1 or ingredients of S-1 2. Patient who takes flucytosine, or phenytoin 3. Severe bone marrow suppression, severe renal dysfunction, or severe liver dysfunction 4. Severe concomitant disease (congestive heart failure, hemorrhagic peptic ulcer, ileus, symptomatic ischemic heart disease, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or etc) 5. Patient who suffered from myocardial infarction or cerebral infarction within six months 6. symptomatic brain metastasis 7. Severe mental disorders 8. Active synchronous malignancy 9. Watery diarrhea 10. HBV carrier who has to take nucleotide analogues (e.g. Entecavir) during chemotherapy 11. Patient who is judged inappropriate for the entry into this study by the investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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