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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00238160
Recruitment Status : Withdrawn
First Posted : October 13, 2005
Last Update Posted : May 30, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE October 12, 2005
First Posted Date  ICMJE October 13, 2005
Last Update Posted Date May 30, 2013
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00238160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer
Official Title  ICMJE Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus
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.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Localized Resectable Adult Primary Liver Cancer
  • Stage III Childhood Liver Cancer
Intervention  ICMJE
  • Drug: cisplatin
  • Drug: fluorouracil
  • Procedure: adjuvant therapy
  • Procedure: chemotherapy
  • Procedure: conventional surgery
  • Procedure: hepatic arterial infusion
  • Procedure: surgery
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 29, 2013)
0
Original Enrollment  ICMJE Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00238160
Other Study ID Numbers  ICMJE KYUH-UHA-HCC02-01
CDR0000363800 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Kyoto University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Iwao Ikai, MD Kyoto University
PRS Account National Cancer Institute (NCI)
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP