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A feasibility study of adjuvant S-1+CDDP for stage III gastric cancer

Phase 2
Recruiting
Conditions
Stage III (the 14th edition of staging system of Japanese Classification of Gastric Carcinoma) gastric cancer based on pathological findings after curative resection.
Registration Number
JPRN-UMIN000013479
Lead Sponsor
Department of Medical Oncology, Toranomon Hospitalnasoi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients who received surgery within 2 weeks before enrollment. 2) Patients with uncontrable diabetis. 3) Patients who has past history of myocardial infarction within 6 months before enrollment or who has unstable angina. 4) Patients who receive anti-arrhythmia drug (except warfarin for atrial fibrillation). 5) Patients with liver chirrosis. 6) Patients with severe renal failure. 7) Patients with ileus or subileus. 8) Patients who receive continuous corticosteroid administration. 9) Patients with active infections. 10) Patients with uncontrollable ascites, pleural effusion or pericardial effusion. 11) Patients with a history of serious drug allergy. 12) Patients with grade 2-4 diarrhea based on CTCAE ver 4. 13) Patients with interstitial pneumonia or pulmonary fibrosis detected by chest X-ray. Pregnant or lactating female. 14) Patients with grade 2-4 neuropathy based on CTCAE ver 4. 15) Patients who recieved transfusion within 2 weeks before enrollment, or has active bleeding. 16) Pregnant or lactating female. 17) Other patients evaluated to be inadequate to participate in this study by investigators.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The proportion of accomplishing three cycles S-1+CDDP therapy
Secondary Outcome Measures
NameTimeMethod
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