A multicenter phase II study of S-1+ramucirumab as first line treatment in elderly patients with advanced/recurrent gastric cancer(KSCC1701)
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000028309
- Lead Sponsor
- Kyushu Study group of Clinical Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 48
Not provided
1)Patients who have severe drug hypersensitivity. 2)Patients who have undergone major surgery up to 28 days prior to enrollment or in whom a central venous access device has been placed up to 7 days prior to the initial treatment. Patients who are scheduled to undergo major surgery during the study period. Patients with a severe hemorrhagic disorder within 12 weeks of enrollment. 3)Patients who have had a gastrointestinal perforation and/or fistula up to 6 months prior to enrollment. 4)Patients with a serious or non-healing wound up to 28 days prior to enrollment. 5)Patients who have had deep vein thrombosis, pulmonary embolism, or some other major form of thromboembolism up to 3 months prior to enrollment. 6)The patient has experienced any arterial thromboembolic events, within 6 months prior to first protocol therapy. 7)Patients receiving chronic administration of a non-steroidal antiinflammatory drug or some other antiplatelet drug. 8)Patients with an active infection. 9)Patients with hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) that cannot be adequately controlled with 2 antihypertensives. 10)Patients with diabetes mellitus that cannot be controlled adequately with medication. 11)Patients with heart disease that may pose a problem. 12)Patients with severe pulmonary disease. 13)Patients with a psychiatric disorder. 14)Patients with active gastrointestinal tract bleeding requiring repeated transfusions. 15)Patients receiving phenytoin, warfarin potassium, or flucytosine. 16)Patients with diarrhea (Grade 2 or worse). 17)Patients with active multiple cancers. 18)Men who wish to conceive with a partner. 19)Patients with hepatic cirrhosis or active hepatitis. 20)Patients with cirrhosis, with a history of hepatic encephalopathy, or with clinically significant ascites. 21)Other patients whom a lead investigator or the patient's primary physician deems are not appropriate for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year survival rate
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Progression-free survival (PFS) Response rate (RR) safety (Safety)