Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis (ACRIN-6673)

American College of Radiology Imaging Network

Status: Completed

Conditions: Liver Cancer

Treatments: Device: radiofrequency ablation

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00132041

U01CA079778 (U.S. NIH Grant/Contract)

ACRIN-6673 (Other Identifier)

U01CA080098 (U.S. NIH Grant/Contract)

CDR0000439446

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

All Patients

Other group

Description:

patients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC.

Treatment:

Device: radiofrequency ablation