Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

NCT00132041 | Completed Results DMC FDA Device

• 4 other identifiers: CDR0000439446ACRIN-6673U01CA080098U01CA079778
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 18

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.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Successful Control of Disease at 18 Months

  Outcome is positive (success) if alive and no disease is observed by CT at 18 months post start of therapy Outcome is negative if the patient was deceased or disease was observed by CT at 18 months post start of therapy Success rate it the fraction of eligible patients who were alive and disease free at 18 months.

  18 months after start of therapy

Secondary Outcomes (7)

• Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation

  18 months after start of therapy

• Effect of Tumor Size on Successful Control of Disease at 18 Months

  18 months after start of therapy

• Local Tumor Recurrence (Control) Rates

  18 months after start of therapy

• Impact of Tumor Size on Local Control Rates

  18 months after start of therapy

• Development of Extra-hepatic Tumor

  18 months after start of therapy

Study Arms (1)

All Patients

OTHER

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

Device: radiofrequency ablation

Interventions

radiofrequency ablation DEVICE

Also known as: RFA

All Patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (18)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Scott and White Cancer Institute

Temple, Texas, 76508, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Donna Harfeil, Director of Protocol Management
• Organization: American College of Radiology Imaging Network

Donna Hartfeil <dhartfeil@acr.org>

215-717-2765

Study Officials

• Gerald D. Dodd, MD

  The University of Texas Health Science Center at San Antonio

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2005
• First Posted: August 19, 2005
• Study Start: December 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: November 1, 2010
• Last Updated: September 10, 2020
• Results First Posted: September 10, 2020

Record last verified: 2020-08

Locations

US (18)