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

This study has been withdrawn prior to enrollment.
(Lack of referrals.)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01669668
First received: August 16, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma, Hepatocellular
Procedure: radiofrequency ablation
Procedure: laparoscopy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation Under Ideal Conditions in Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Local recurrence, defined as the recurrence at the size of original tumor [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Local recurrence will be summarized using descriptive statistics.


Secondary Outcome Measures:
  • Morbidity and mortality associated with RFA under ideal conditions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The incidences of surgical complications and procedure-related death will be calculated.

  • Overall survival rate [ Time Frame: At 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: December 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RFA
Patients undergo laparoscopic ultrasound followed by RFA.
Procedure: radiofrequency ablation
Undergo RFA
Procedure: laparoscopy
Undergo laparoscopic ultrasound

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669668

Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Steven Strasberg, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01669668     History of Changes
Other Study ID Numbers: 201207113
Study First Received: August 16, 2012
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2014