Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer
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.
|Localized Resectable Adult Primary Liver Cancer Stage III Childhood Liver Cancer||Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Procedure: chemotherapy Procedure: conventional surgery Procedure: hepatic arterial infusion Procedure: surgery||Phase 3|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus|
- Compare the efficacy of surgical resection with vs without postoperative hepatic arterial chemotherapy in patients with hepatocellular carcinoma and portal vein tumor thrombus.
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.
- Arm I: Patients undergo macroscopic curative resection. Within 28 days after surgery, patients without post-surgery complications undergo hepatic arterial infusion comprising fluorouracil and cisplatin on days 1-5, 8-12, and 15-19. Treatment continues for 6 months.
- Arm II: Patients undergo macroscopic curative resection.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238160
|Kyoto Prefectural University of Medicine|
|Kyoto, Japan, 602-8566|
|Kyoto City Hospital|
|Kyoto, Japan, 604-8845|
|Kyoto University Hospital|
|Kyoto, Japan, 606-8501|
|Kyoto, Japan, 615-8256|
|Study Chair:||Iwao Ikai, MD||Kyoto University|