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

Primary Purpose

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

Status
Withdrawn
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
cisplatin
fluorouracil
adjuvant therapy
chemotherapy
conventional surgery
hepatic arterial infusion
surgery
Sponsored by
Kyoto University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Localized Resectable Adult Primary Liver Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyoto Prefectural University of Medicine
  • Kyoto City Hospital
  • Kyoto University Hospital
  • Kyoto-Katsura Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 12, 2005
Last Updated
May 29, 2013
Sponsor
Kyoto University
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1. Study Identification

Unique Protocol Identification Number
NCT00238160
Brief Title
Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer
Official Title
Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kyoto University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Resectable Adult Primary Liver Cancer, Stage III Childhood Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
chemotherapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
hepatic arterial infusion
Intervention Type
Procedure
Intervention Name(s)
surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iwao Ikai, MD
Organizational Affiliation
Kyoto University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Kyoto City Hospital
City
Kyoto
ZIP/Postal Code
604-8845
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8501
Country
Japan
Facility Name
Kyoto-Katsura Hospital
City
Kyoto
ZIP/Postal Code
615-8256
Country
Japan

12. IPD Sharing Statement

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

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