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

NCT00238160 | Withdrawn Phase 3

• 2 other identifiers: KYUH-UHA-HCC02-01CDR0000363800
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Interventions

cisplatin DRUG

fluorouracil DRUG

adjuvant therapy PROCEDURE

chemotherapy PROCEDURE

conventional surgery PROCEDURE

hepatic arterial infusion PROCEDURE

surgery PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kyoto University: lead

Study Sites (4)

Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Kyoto City Hospital

Kyoto, 604-8845, Japan

Location

Kyoto University Hospital

Kyoto, 606-8501, Japan

Location

Kyoto-Katsura Hospital

Kyoto, 615-8256, Japan

Location

MeSH Terms

Interventions

Cisplatin; Fluorouracil; Chemotherapy, Adjuvant; Drug Therapy; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics

Study Officials

• Iwao Ikai, MD

  Kyoto University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 13, 2005
• Last Updated: May 30, 2013

Record last verified: 2006-07

Locations

JP (4)