- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00238160
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
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.
Study Overview
Status
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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Kyoto, Japan, 602-8566
- Kyoto Prefectural University of Medicine
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Kyoto, Japan, 606-8501
- Kyoto University Hospital
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Kyoto, Japan, 615-8256
- Kyoto-Katsura Hospital
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Kyoto, Japan, 604-8845
- Kyoto City Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Iwao Ikai, MD, Kyoto University
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Fluorouracil
Other Study ID Numbers
- KYUH-UHA-HCC02-01
- CDR0000363800 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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