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

Phase 2

Withdrawn

• Conditions: Carcinoma, Hepatocellular
• Interventions: Procedure: radiofrequency ablation; Procedure: laparoscopy

• Registration Number: NCT01669668
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-21
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16
• Study Start: 2014-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RFA	radiofrequency ablation	Patients undergo laparoscopic ultrasound followed by RFA.
RFA	laparoscopy	Patients undergo laparoscopic ultrasound followed by RFA.

Primary Outcome Measures

Name	Time	Method
Local recurrence, defined as the recurrence at the size of original tumor	Up to 2 years	Local recurrence will be summarized using descriptive statistics.

Secondary Outcome Measures

Name	Time	Method
Morbidity and mortality associated with RFA under ideal conditions	30 days	The incidences of surgical complications and procedure-related death will be calculated.
Disease-free survival rate	At 2 years	Kaplan-Meier product limit method will be used to estimate the 2-year disease-free survival. The median disease-free survival will also be estimated.
Overall survival rate	At 2 years	Kaplan-Meier product limit method will be used to estimate the 2-year overall survival. The median overall survival will also be
Ability of patients who develop recurrence to undergo salvage transplantation	Up to 2 years	At the time of recurrence, the patient is evaluated to see if she/he falls within the Milan criteria; if she/he does, then she/he is considered able to undergo salvage transplantation.