Phase II study of ramucirumab plus paclitaxel therapy for elderly patients with non-resectable or metastatic gastric cancer (T-CORE1501)
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000021728
- Lead Sponsor
- Tohoku Clinical Oncology Research and Education Society (T-CORE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 30
Not provided
Patients who fulfill the following criteria for exclusion are excluded. 1) Received taxane-based regimen. 2) Synchronous double cancer or past history of other cancer within 5 years, except curable carcinoma in situ and skin cancer. 3) Active infection and inflammation. 4) Active hepatitis. 5) Current or past history within 1 year of serious heart disease that requires hospitalization 6) Serious complications or severe complications that require hospitalization for therapy, such as gastrointestinal paresthesia, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrollable hypertension, diabetes mellitus, renal dysfunction, liver dysfunction, and hepatic cirrhosis. 7) Active gastrointestinal bleeding. 8) Gastrointestinal perforation or histula, artelial embolism within 6 months or venous thromboembolism within 3 months before registration. 9) Receiving medications with psychotropic drugs for mental disorders, or having mental disorders that require medications with psychotropic drugs. 10) Grade 2 or more neuropathy. 11) Effusion that requires drainage. 12) Determined to be inappropriate to enter the study by the responsible researcher or contributing researchers, for any other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival
- Secondary Outcome Measures
Name Time Method OS. ORR, TTF, DCR, toxicity, correlation between CGA screening score and efficacy/toxicity