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Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)

Phase 2
Conditions
gastric neoplasm
Registration Number
JPRN-C000000138
Lead Sponsor
Japan Clinical Oncology Group(JCOG)
Brief Summary

See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

Exclusion Criteria

(1) diabetes mellitus, uncontrolled or controlled with insulin (2) unstable angina, or myocardial infarction within 6 months prior to the study (3) arrhythmia, needing medical intervention (4) hypersensitivity to alcohol (5) HBs antigen or their HCV antibody are positive (6) massive pleural effusion (7) Grade 3-4 diarrhea (CTCAE ver3.0) (8) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (9) pregnant or lactating women (10) severe mental disease (11) not appropriate for the trial at the physician's assessment

Study & Design

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