A phase III trial to confirm S-1 adjuvant chemotherapy for pathological stage II/III vulnerable elderly gastric cancer patients who underwent gastric resection (JCOG1507, BIRDIE)
- Conditions
- Gastric neoplasm
- Registration Number
- JPRN-UMIN000025742
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 370
Not provided
1) Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shorter 2) Infectious disease requiring systemic treatment 3) Body temperature of 38 degrees Celsius or higher 4) Severe mental disease 5) Requiring systemic steroid medication (>= 5 mg/day of prednisolone) 6) Under treatment by flucytosine, phenytoin, or warfarin potassium 7) Uncontrolled diabetes mellitus 8) Uncontrolled hypertension 9) Unstable angina pectoris (angina developed or attack worsened within recent 3 weeks) or previous myocardial infarction within 6 months 10) Positive for HBs antigen 11) Severe interstitial pneumonia, severe lung fibrosis, or severe emphysema 12) Surgical morbidity such as infection, leakage, intestinal bleeding, pancreatic fistula, and so on is not improved
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method