Randomized Phase II Study of 5-fluorouracil Hepatic Arterial Infusion With or Without Antineoplastons as an Adjuvant Therapy After Hepatectomy for Liver Metastases from Colorectal Cancer
Phase 2
- Conditions
- iver Metastases from Colorectal Cancer
- Registration Number
- JPRN-UMIN000012099
- Lead Sponsor
- Kurume University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)No treatment with chemotherapeutics and radiation 2)Simultaneous or metachronous double cancers 3)Pregnant or lactating women or women of childbearing potential 4)Other patients who are unfit for the study as determined by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective was to determine whether systemic administration of antineoplastons added to adjuvant 5-FU HAI after liver resection increased cause-specific survival (CSS).
- Secondary Outcome Measures
Name Time Method Secondary endpoints were evaluation of relapse-free survival (RFS), grade of recurrence and toxicity.