Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00132041
• Date of registration: 16/08/2005
• Prospective Registration: Yes
• Primary sponsor: American College of Radiology Imaging Network
• Public title: Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis ACRIN-6673
• Scientific title: Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
• Date of first enrolment: December 2005
• Target sample size: 51
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00132041
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Gerald D. Dodd, MD
• Affiliation: The University of Texas Health Science Center at San Antonio

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 120 Years
Gender: All

Health Condition(s) or Problem(s) studied

Liver Cancer

Intervention(s)

Device: radiofrequency ablation

Primary Outcome(s)

Proportion of Participants With Successful Control of Disease at 18 Months [Time Frame: 18 months after start of therapy]

Secondary Outcome(s)

Development of Extra-hepatic Tumor [Time Frame: 18 months after start of therapy]

Local Tumor Recurrence (Control) Rates [Time Frame: 18 months after start of therapy]

Local Tumor Eradication Rate by Examination of Liver Via Autopsy or Transplant vs That Determined by CT Scan [Time Frame: 18 months after start of therapy]

Effect of Tumor Size on Successful Control of Disease at 18 Months [Time Frame: 18 months after start of therapy]

Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation [Time Frame: 18 months after start of therapy]

Impact of Tumor Size on Local Control Rates [Time Frame: 18 months after start of therapy]

Remote Tumor Occurrence Rates [Time Frame: 18 months after start of therapy]

Secondary ID(s)

U01CA079778

U01CA080098

CDR0000439446

ACRIN-6673

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Results

• Results available: Yes
• Date Posted: 10/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00132041