Clinical trial NCT00132041: Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis
Official title: Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Keywords: adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer
Lead sponsor: American College of Radiology Imaging Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-08-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 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

Primary outcomes:
measure: Proportion of Participants With Successful Control of Disease at 18 Months
timeFrame: 18 months after start of therapy
Secondary outcomes:
measure: Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation
timeFrame: 18 months after start of therapy
measure: Effect of Tumor Size on Successful Control of Disease at 18 Months
timeFrame: 18 months after start of therapy
measure: Local Tumor Recurrence (Control) Rates
timeFrame: 18 months after start of therapy
measure: Impact of Tumor Size on Local Control Rates
timeFrame: 18 months after start of therapy
measure: Development of Extra-hepatic Tumor
timeFrame: 18 months after start of therapy
measure: Local Tumor Eradication Rate by Examination of Liver Via Autopsy or Transplant vs That Determined by CT Scan
timeFrame: 18 months after start of therapy
measure: Remote Tumor Occurrence Rates
timeFrame: 18 months after start of therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Cancer Center - University Campus
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Royal Oak Campus
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital Comprehensive Cancer Center
state: Rhode Island
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: M. D. Anderson Cancer Center at University of Texas
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Temple
country: United States
facility: Scott and White Cancer Institute
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Gerald D. Dodd, MD
role: STUDY_CHAIR
References: