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Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer

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Trial Information

Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

No identifiable tumor by CT scan 18 months after start of therapy

Safety Issue:

No

Principal Investigator

Gerald D. Dodd, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Health Science Center at San Antonio

Authority:

United States: Federal Government

Study ID:

CDR0000439446

NCT ID:

NCT00132041

Start Date:

December 2005

Completion Date:

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • localized unresectable adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
University of California Davis Cancer CenterSacramento, California  95817
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Scott and White Cancer InstituteTemple, Texas  76508