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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00238160

Enrollment

Registered

2005-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Interventions

DRUGcisplatin

DRUGfluorouracil

PROCEDUREadjuvant therapy

PROCEDUREchemotherapy

PROCEDUREconventional surgery

PROCEDUREhepatic arterial infusion

PROCEDUREsurgery

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026