Phase II study of Capecitabine + oxaliplatin(CapeOx) for elderly patients with untreated metastatic gastric cancer <TCOG GI-1601>
Not Applicable
- Conditions
- ntreated metastatic gastric cancer
- Registration Number
- JPRN-UMIN000022450
- Lead Sponsor
- The Tokyo Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Not provided
Exclusion Criteria
1) Blood transfusion, blood products or G-CSF within 21 days at registration 2) Peripheral sensory neuropathy: Grade 1 or greater 3) Uncontrolled hypertension or diabetes; interstitial pneumonia, pulmonary fibrosis, or severe emphysema; renal failure, hepatic failure, active gastrointestinal bleeding, stroke in 3 months 4) Abnormal electrocardiogram 5) More than moderate dose of ascites, massive pleural effusion 6) Brain metastasis 7) Extensive bone metastasis 8) Multiple primary cancers 9) HBs antigen positive, HCV or HIV antibody positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Progression-free survival Time to treatment failure Response rate Relative dose intensity Incidence of adverse events Geriatric Assessment