A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go.
- Conditions
- unresectable colorectal cancer
- Registration Number
- JPRN-UMIN000022535
- Lead Sponsor
- Gunma University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
1. The cases with serious drug hypersensitivity or allergy. 2. Pregnant or men who expect the partner's pregnancy. 3. The cases with infectious disease requiring systemic therapy. 4. The cases with serious complications - Interstitial pneumonia, pulmonary fibrosis - Heart failure - Renal failure - Liver failure - Poor control diabetes mellitus - Poor control high blood pressure 5. Cases with ECG abnormalities are found or heart disease as a clinical problem , ( heart failure , myocardial infarction , angina pectoris). 6. Cases with gastrointestinal ulceration or bleeding. 7. Pre-existing with hemoptysis. 8. Cases with peripheral nerve disorder. 9. Patients who need a treatment for abdominal dropsy and pleural effusion. 10. Possibility of brain metastasis. 11. Perforation of the digestive tract within 6 months from the day of registration. 12. Pre-existing with thromboembolism, cerebral infarction, lung infarction and pneumonitis. 13. Surgery within 28 days from the registration day. 14. Bleeding tendency 15. Multiple primary cancers 16. Constitutional administration therapy with steroid 17. The cases judged to be unsuitable for registration. 18. Primary lesion with stricture 19. Cases with peritoneal metastasis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS: Progression-free survival
- Secondary Outcome Measures
Name Time Method