Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)

The Washington University

Status and phase

Withdrawn

Phase 2

Conditions

Carcinoma, Hepatocellular

Treatments

Procedure: radiofrequency ablation

Procedure: laparoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01669668

201207113

Details and patient eligibility

About

This phase II trial studies how effectively radiofrequency ablation prevents recurrence of hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells.

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically proven HCC or unambiguous radiologic findings consistent with HCC (> 1 cm tumor with arterial hypervascularity and venous or delayed phase washout) in patients with underlying liver disease.
Disease must be considered unresectable (as defined by protocol).
Age between 18 and 69 (inclusive).
Karnofsky performance status of ≥ 80%
Normal organ and marrow function as defined below:
leukocytes ≥3,000/mcL
absolute neutrophil count ≥1,500/mcL
platelets >100,000/mcL
total bilirubin <2.0 mg/dL
AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
creatinine within normal institutional limits OR
creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Presence of ≤ 3 tumors, all of which are ≤ 3 cm in size. This will be determined preoperatively and confirmed by intraoperative ultrasound.
Liver function of Child-Pugh class A or B
Tumor(s) must be more than 2 cm away from of major biliary duct or major blood vessel defined as the main portal vein and its right and left primary branches and the first 1 cm of the secondary branches of the common hepatic duct and its right and left primary branches or the first 1 cm of its secondary branches.
Able to understand and willing to sign a written informed consent document.

Exclusion criteria

Hepatic tumor(s) with satellite lesions. A satellite lesion is defined as a tumor which is within 2 cm of the tumor being assessed for treatment and which has a diameter of less than 33% of the diameter of the tumor being assessed for treatment.
Evidence of metastatic/extrahepatic disease based on abdominal and chest CT performed within 4 weeks of the procedure.
Extrahepatic disease upon laparoscopy performed at the time of RFA. If extrahepatic disease is discovered at this laparoscopy, RFA will not be performed, and the patient will be considered ineligible for this study and will be replaced.
Pregnancy. All women of childbearing potential must have a negative pregnancy test prior to enrollment in the study.
Significant portal hypertension based on evidence of esophageal varices or ascites. Minimal portal hypertension or ascites will not be an exclusion criterion.
Previous history of HCC or any other non-cutaneous malignancy.

Patients who are found to be ineligible due to intraoperative findings will be recorded as to the cause of ineligibility. They will not be counted as accrued patients.

-Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.