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

Carcinoma, Hepatocellular Clinical Trial

Official title:

Radiofrequency Ablation Under Ideal Conditions in Hepatocellular Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01669668
• Other study ID #: 201207113
• Status: Withdrawn
• Phase: Phase 2
• First received: August 16, 2012
• Last updated: July 15, 2014
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: July 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Procedure:
• radiofrequency ablation
Undergo RFA
• laparoscopy
Undergo laparoscopic ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence, defined as the recurrence at the size of original tumor	Local recurrence will be summarized using descriptive statistics.	Up to 2 years	No
Secondary	Morbidity and mortality associated with RFA under ideal conditions	The incidences of surgical complications and procedure-related death will be calculated.	30 days	Yes
Secondary	Overall survival rate	Kaplan-Meier product limit method will be used to estimate the 2-year overall survival. The median overall survival will also be	At 2 years	No
Secondary	Disease-free survival rate	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.	At 2 years	Yes
Secondary	Ability of patients who develop recurrence to undergo salvage transplantation	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.	Up to 2 years	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine