A Phase II trial of Panitumumab with irinotecan/S-1(IRIS) as 1st-line chemotherapy for KRAS wild type metastatic colorectal cancer
- Conditions
- KRAS wild type metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000008496
- Lead Sponsor
- Tohoku-Six Universities Research Group by Experts(T-SURGE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Not provided
1. Patients who have allergy for drugs. 2. Patients who have other malignancies. 3. Infectuins in active. 4. Patients who have past histories of bowel perforation and/or bowel obstruction in one year before registration. 5. Serious complications (e.g.,interstitial pneumonitis, pulmonary fibrosis, heart failure, renal failure, hepatic failure or uncontrolled high blood pressure or diabetes mellitus). 6. Pleural effusion and/or ascites to need treatment. 7. Watery diarrhea. 8. Patients who have given a dose of flucytosine or atazanavir sulfate. 9. Patients who have brain metastases. 10. Pregnant woman, nursing mothers, possibly pregnant woman and wishing to become pregnant. 11. Patients who have severe mental disease. 12. The Patient that a study responsibility physician judged to be inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression free survival, Disease control rate, Time to treatment failure, Duration of response, Resection rate of metastases, Adverse events