Overview

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

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kyoto University
Treatments:
Fluorouracil
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