Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01669668 |
Recruitment Status
:
Withdrawn
(Lack of referrals.)
First Posted
: August 21, 2012
Last Update Posted
: July 16, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Hepatocellular | Procedure: radiofrequency ablation Procedure: laparoscopy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Radiofrequency Ablation Under Ideal Conditions in Hepatocellular Carcinoma |
Study Start Date : | December 2014 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: RFA
Patients undergo laparoscopic ultrasound followed by RFA.
|
Procedure: radiofrequency ablation
Undergo RFA
Procedure: laparoscopy
Undergo laparoscopic ultrasound
|
- Local recurrence, defined as the recurrence at the size of original tumor [ Time Frame: Up to 2 years ]Local recurrence will be summarized using descriptive statistics.
- Morbidity and mortality associated with RFA under ideal conditions [ Time Frame: 30 days ]The incidences of surgical complications and procedure-related death will be calculated.
- Overall survival rate [ Time Frame: 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
- Disease-free survival rate [ Time Frame: 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.
- Ability of patients who develop recurrence to undergo salvage transplantation [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 69 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669668
Principal Investigator: | Steven Strasberg, M.D. | Washington University School of Medicine |
Additional Information:
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT01669668 History of Changes |
Other Study ID Numbers: |
201207113 |
First Posted: | August 21, 2012 Key Record Dates |
Last Update Posted: | July 16, 2014 |
Last Verified: | July 2014 |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |