Clinical trial NCT00238160: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Localized Resectable Adult Primary Liver Cancer
Stage III Childhood Liver Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-10-13
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto City Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Kyoto
country: Japan
facility: Kyoto-Katsura Hospital
Study officials:
affiliation: Kyoto University Hospital
name: Iwao Ikai, MD
role: STUDY_CHAIR
References: