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

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ClinicalTrials.gov Identifier: NCT01669668
Recruitment Status : Withdrawn (Lack of referrals.)
First Posted : August 21, 2012
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Procedure: radiofrequency ablation Procedure: laparoscopy Phase 2

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: RFA
Patients undergo laparoscopic ultrasound followed by RFA.
 Procedure: radiofrequency ablation
Undergo RFA

Procedure: laparoscopy
Undergo laparoscopic ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Steven Strasberg, M.D. Washington University School of Medicine
More Information
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Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

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