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A randomized controlled trial comparing gastrectomy plus chemotherapy with chemotherapy alone in advanced gastric cancer with a single non-curable factor (JCOG0705/KGCA01)

Phase 3
Conditions
clinical stage IV gastric cancer
Registration Number
JPRN-UMIN000001012
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
330
Inclusion Criteria

Not provided

Exclusion Criteria

1) Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 2) Women during pregnancy or breast-feeding. 3) Psychosis. 4) Systemic steroids medication. 5) Medication of furucytocin, fenytoin, or warfarin. 6) Active bacterial infection or mycosis, affecting systemic condition. 7) Myocardial infarction or unstable angina, occurred within 6 months. 8) Uncontrollable hypertension. 9) Uncontrollable diabetes mellitus or administration of insulin. 10) Pulmonary disease necessitating continuous oxygen supply.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
overall survival
Secondary Outcome Measures
NameTimeMethod
progression-free survival, adverse events
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