N/A N=51 Treatment

Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

Liver Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00132041 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Sep 2020

Primary outcome: Primary: Proportion of Participants With Successful Control of Disease at 18 Months — .18 proportion of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: radiofrequency ablation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: American College of Radiology Imaging Network
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants With Successful Control of Disease at 18 Months	.18	—
SECONDARY Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation	5; 3; 30; 7	0.0004 sig
SECONDARY Effect of Tumor Size on Successful Control of Disease at 18 Months	2.80; 3.32	0.0221 sig
SECONDARY Local Tumor Recurrence (Control) Rates	0.51	—
SECONDARY Impact of Tumor Size on Local Control Rates	2.4833; 2.9417	0.06
SECONDARY Development of Extra-hepatic Tumor	2; 25; 4; 14	—
SECONDARY Local Tumor Eradication Rate by Examination of Liver Via Autopsy or Transplant vs That Determined by CT Scan	3; 11; 1; 1	—
SECONDARY Remote Tumor Occurrence Rates	0.53	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00132041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.