A phase I/II study of hepatic arterial 5-flurouracil (5FU) combined with intravenous irinotecan hydrochloride (CPT-11) for metastatic colorectal cancer isolated in the liver. (JCOG 0208-DI)
Phase 1
- Conditions
- Metastatic colorectal cancer isolated in the liver
- Registration Number
- JPRN-C000000051
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) Massive pleural effusion or massive ascites. 2) Active bleeding from digestive organ. 3) Active infection. 4) Watery diarrhea. 5) Other uncontrolled severe illness. 6) Active other malignancy. 7) Prior radiation therapy for abdomen. 8) Positive hepatitis-B antigen or anti-hepatitis-C antibody. 9) Allergy to iodine contrast medium resulting in preclusion of angiography. 10) Severe mental disorder. 11) Pregnant or nursing. 12) Prior placement of hepatic arterial catheter and port system.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method