Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000006487
- Lead Sponsor
- Chube Clinical Oncology Group (CCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 34
Not provided
(1)Uncontrolled infection. (2)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (3)Severe lung disease. (4)Interstitial lung disease or pulmonary fibrosis. (5)Severe liver disease. (6)Severe renal failure, or urinary protein (more than 2+). (7)Previous history of severe drug-induced allergy (8)ileus, bowel obstruction (9)Uncontrolled severe complications (DM, hypertension, diarrhea, et al.). (10)History of active double cancer. (11)Massive pleural effusion or ascites that required drainage. (12)Brain metastasis (13)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (14)Not appropriate for the study at the physician's assessment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method One year survival rate, Overall survival, Response rate, Disease control rate, Time to treatment failure, Toxicity