Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
American College of Radiology Imaging Network
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00132041
First received: August 16, 2005
Last updated: February 6, 2009
Last verified: November 2007
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Purpose
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. CT-, MRI-, or ultrasound-guided radiofrequency ablation may be an effective treatment for liver cancer and cirrhosis.
PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating patients with liver cancer and cirrhosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Procedure: radiofrequency ablation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- No identifiable tumor by CT scan 18 months after start of therapy [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Solitary vs repetitive radiofrequency ablation Impact on the primary objective 18 months after start of therapy [ Designated as safety issue: No ]
- Tumor size impact on the primary objective 18 months after start of therapy [ Designated as safety issue: No ]
- Correlate Model for End-Stage Liver Disease (MELD) score and the primary objective 18 months after start of therapy [ Designated as safety issue: No ]
- Local and remote tumor recurrence rates 18 months after start of therapy [ Designated as safety issue: No ]
- Impact of tumor size on local control rates 18 months after start of therapy [ Designated as safety issue: No ]
- Impact of solitary or repetitive radiofrequency ablation (RFA) with or without local control on development of extra-hepatic tumor [ Designated as safety issue: No ]
- Local tumor eradication rate by examination of liver via autopsy or transplant vs that determined by CT scan [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2005 |
OBJECTIVES:
Primary
- Determine the 18-month successful disease control rate, defined as no identifiable liver tumor by CT scan, in patients with hepatocellular carcinoma and cirrhosis treated with solitary or repetitive percutaneous radiofrequency ablation (RFA).
Secondary
- Correlate tumor size, MELD score, and the number of RFA treatments (solitary or repetitive) with the 18-month successful disease control rate in patients treated with this procedure.
- Determine the local and remote intrahepatic and extrahepatic tumor recurrence rates in patients treated with this procedure.
- Correlate local and remote intrahepatic and extrahepatic tumor recurrence rates with the 18-month successful disease control rate in patients treated with this procedure.
- Correlate tumor size with the local disease control rate in patients treated with this procedure.
- Correlate solitary or repetitive RFA with or without local/regional tumor control with the development of extrahepatic tumor in these patients.
- Determine the local tumor eradication rate, as determined by examination of whole liver specimens or CT scan, in patients treated with this procedure.
OUTLINE: This is a multicenter study. Patients are stratified according to hepatic dysfunction using the MELD score (< 15 vs 15-25 vs > 25).
Patients undergo placement of an ablation electrode percutaneously into the tumor(s) by CT scan, MRI, or ultrasound guidance. Patients then undergo percutaneous radiofrequency ablation (RFA) directly to the tumor(s) for 12 minutes. Patients undergo CT scan of the liver within 1 week after RFA treatment and then every 3 months for up to 18 months. Patients with residual or recurrent intrahepatic tumor(s) detectable on the 3-month or subsequent CT scan undergo repeat RFA as is technically feasible and clinically indicated for up to 15 months after initial RFA treatment.
After completion of study treatment, patients are followed at 1 day, 1 week, 1 month, and then every 3 months for up to 18 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of hepatocellular carcinoma (HCC), meeting 1 of the following criteria:
- Histologically confirmed HCC
Discrete non-biopsied hepatic tumors, meeting 1 of the following criteria:
- Hypervascular tumor > 2 cm by 2 imaging studies
- Hypervascular tumor > 2 cm by a single imaging study AND alpha-fetoprotein ≥ 400 ng/mL
- Discrete non-biopsied hypervascular hepatic tumors by 2 consecutive imaging studies (e.g., CT scan or MRI) with documented tumor growth > 1 cm in diameter
- Histologically confirmed cirrhosis OR typical findings of cirrhosis (i.e., nodular liver, splenomegaly, varices, or ascites) by CT scan and/or MRI scan
Single hepatic tumor > 3.0 cm but ≤ 5.0 cm in diameter OR 3 or fewer hepatic tumors ≤ 3.0 cm in diameter
- No excessive intrahepatic tumor burden (i.e., > 3 hepatic tumors OR a single hepatic tumor > 5 cm OR more than 3 vague hypervascular nodules > 1 cm)
Tumor(s) ≥ 1 cm from the main, right, and left portal veins and hollow viscera
- No hepatic or portal vein tumor invasion
- Tumor(s) > 1 cm treatable by percutaneous radiofrequency ablation
- No extrahepatic tumor
Not a surgical candidate due to any of the following reasons:
- Tumor in an unresectable location
- Comorbid disease
- Insufficient hepatic reserve
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- No uncorrectable coagulopathy
Hepatic
- Not specified
Renal
- Creatinine ≤ 2.0 mg/dL
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active symptomatic bacterial or fungal infection that is newly diagnosed and/or requires treatment
- No absolute contraindication to IV iodinated contrast (i.e., history of significant contrast reaction not mitigated by appropriate premedication)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior or concurrent chemotherapy for HCC
- No prior or concurrent chemoembolization for HCC
Endocrine therapy
- Not specified
Radiotherapy
- No prior or concurrent radiotherapy for HCC
Surgery
- No prior choledochoenteric anastomosis
- No prior sphincterotomy of duodenal papilla
Other
- No prior or concurrent cryoablation for HCC
- No other prior or concurrent therapy for HCC
- At least 7 days since prior aspirin
- At least 24 hours since prior ibuprofen
- At least 12 hours since prior low molecular weight heparin preparations
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132041
Locations
| United States, Alabama | |
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, Rhode Island | |
| Rhode Island Hospital Comprehensive Cancer Center | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| Scott and White Cancer Institute | |
| Temple, Texas, United States, 76508 | |
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
| Study Chair: | Gerald D. Dodd, MD | University of Texas Health Science Center at San Antonio |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00132041 History of Changes |
| Obsolete Identifiers: | NCT00399958 |
| Other Study ID Numbers: | CDR0000439446, ACRIN-6673 |
| Study First Received: | August 16, 2005 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013