A Phase 3 interventional study of cisplatin and fluorouracil in Localized Resectable Adult Primary Liver Cancer and Stage III Childhood Liver Cancer, sponsored by Kyoto University. Withdrawn at 4 sites in Japan. Per ClinicalTrials.gov, last updated 2013-05-30.
Sponsored by Kyoto University · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether surgery and hepatic arterial chemotherapy are more effective than surgery alone in treating patients with liver cancer that has spread to the portal vein.
PURPOSE: This randomized phase III trial is studying surgery and hepatic arterial chemotherapy to see how well they work compared to surgery alone in treating patients with liver cancer that has spread to the portal vein.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to grade of portal invasion and Child-Pugh classification. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
Browse Liver Neoplasms studies →Kyoto University is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
This study is withdrawn, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.
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Kyoto University