Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus

Conditions
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Localized Resectable Adult Primary Liver Cancer, Stage III Childhood Liver Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: fluorouracil
* Procedure: adjuvant therapy
* Procedure: chemotherapy
* Procedure: conventional surgery
* Procedure: hepatic arterial infusion
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed hepatocellular carcinoma (HCC) with portal vein tumor thrombus Tumor thrombus in the main trunk or first branch of the portal vein No apparent distant metastases on chest CT scan and bone scintigraphy within the past 6 weeks No pleural effusion or ascites PATIENT CHARACTERISTICS: Age Not specified Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Neutrophil count > 1,000/mm^3 Platelet count > 50,000/mm^3 Hemoglobin > 8 g/dL Hepatic Bilirubin < 2 times upper limit of normal (ULN) ALT and AST < 4 times ULN Renal Creatinine normal Cardiovascular No severe heart disease No cardiac effusion Other No other malignant disease No high risk for esophageal varices rupture No allergy to fluorouracil or cisplatin PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior hepatic arterial chemotherapy No prior systemic chemotherapy for HCC Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: fluorouracil|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: chemotherapy|nan|
|Procedure: conventional surgery|nan|
|Procedure: hepatic arterial infusion|nan|
|Procedure: surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |