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

Status:

WITHDRAWN

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

Lead Sponsor:

Kyoto University

Conditions:

Localized Resectable Adult Primary Liver Cancer

Stage III Childhood Liver Cancer

Eligibility:

All Genders

Phase:

PHASE3

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. Givi...

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...

Eligibility Criteria

Inclusion

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

Exclusion

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00238160

Last Update

May 30 2013

Active Locations (4)

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Page 1 of 1 (4 locations)

Kyoto Prefectural University of Medicine

Kyoto, Japan, 602-8566

Kyoto City Hospital

Kyoto, Japan, 604-8845

Kyoto University Hospital

Kyoto, Japan, 606-8501