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A phase III trial to evaluate bursectomy for patients with SS/SE gastric cancer (JCOG1001, BURSECTOMY PHASE III)

Phase 3
Conditions
cT3(SS) or cT4a(SE) gastric cancer
Registration Number
JPRN-UMIN000003688
Lead Sponsor
Japan Clinical Oncology Group (JCOG)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
1200
Inclusion Criteria

Not provided

Exclusion Criteria

1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ 2) Infectious disease with systemic therapy indicated 3) Body temperature is higher than 38 degrees centigrade 4) Women during pregnancy or breast-feeding 5) Severe mental disease 6) Continuous systemic steroid therapy 7) Unstable angina pectoris or history of myocardial infarction within 6 months 8) Uncontrollable hypertension 9) Uncontrollable diabetes millutus or administration of insulin 10) Severe respiratory disease requiring continuous oxygen therapy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall survival
Secondary Outcome Measures
NameTimeMethod
Progression-free survival, blood loss, operation time, surgical complications, adverse events of adjuvant chemotherapy
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