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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
radiofrequency ablation
Sponsored by
American College of Radiology Imaging Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  • Jonsson Comprehensive Cancer Center at UCLA
  • University of California Davis Cancer Center
  • Winship Cancer Institute of Emory University
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • UMASS Memorial Cancer Center - University Campus
  • William Beaumont Hospital - Royal Oak Campus
  • Mayo Clinic Cancer Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Wake Forest University Comprehensive Cancer Center
  • Abramson Cancer Center of the University of Pennsylvania
  • Rhode Island Hospital Comprehensive Cancer Center
  • Hollings Cancer Center at Medical University of South Carolina
  • M. D. Anderson Cancer Center at University of Texas
  • University of Texas Health Science Center at San Antonio
  • Scott and White Cancer Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All Patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation
this outcome measures the impact of Solitary vs repetitive radiofrequency ablation on success. Success is defined as the number of patients centrally determined to be alive and tumor-free 18 months after start of therapy, corrected for repetitive RFA.
Effect of Tumor Size on 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. Tumor size is a continuous variable as measured at imaging.
Local Tumor Recurrence (Control) Rates
local tumor control rate is defined as a tumor that was ablated and was not seen again within the 18 month period
Impact of Tumor Size on Local Control Rates
Lesion level local control is defined as a success if a tumor is ablated and does not recur in 18 mo.
Development of Extra-hepatic Tumor
Whether or not extrahepatic tumors were seen at 18months post ablation will be compared with the number of RFA sessions.
Local Tumor Eradication Rate by Examination of Liver Via Autopsy or Transplant vs That Determined by CT Scan
the primary outcome was evidence of existing tumor on pathologic review of the liver at the time or transplant or autopsy within the 18 month observational period. This outcome was compared to the CT HCC detection.
Remote Tumor Occurrence Rates
remote tumor occurrence rate is defined as a new intrahepatic tumor that developed remote from the ablation site within the 18 month period

Full Information

First Posted
August 16, 2005
Last Updated
August 21, 2020
Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00132041
Brief Title
Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis
Acronym
ACRIN-6673
Official Title
Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Patients
Arm Type
Other
Arm Description
patients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC.
Intervention Type
Device
Intervention Name(s)
radiofrequency ablation
Other Intervention Name(s)
RFA
Primary Outcome Measure Information:
Title
Proportion of Participants With Successful Control of Disease at 18 Months
Description
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.
Time Frame
18 months after start of therapy
Secondary Outcome Measure Information:
Title
Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation
Description
this outcome measures the impact of Solitary vs repetitive radiofrequency ablation on success. Success is defined as the number of patients centrally determined to be alive and tumor-free 18 months after start of therapy, corrected for repetitive RFA.
Time Frame
18 months after start of therapy
Title
Effect of Tumor Size on Successful Control of Disease at 18 Months
Description
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. Tumor size is a continuous variable as measured at imaging.
Time Frame
18 months after start of therapy
Title
Local Tumor Recurrence (Control) Rates
Description
local tumor control rate is defined as a tumor that was ablated and was not seen again within the 18 month period
Time Frame
18 months after start of therapy
Title
Impact of Tumor Size on Local Control Rates
Description
Lesion level local control is defined as a success if a tumor is ablated and does not recur in 18 mo.
Time Frame
18 months after start of therapy
Title
Development of Extra-hepatic Tumor
Description
Whether or not extrahepatic tumors were seen at 18months post ablation will be compared with the number of RFA sessions.
Time Frame
18 months after start of therapy
Title
Local Tumor Eradication Rate by Examination of Liver Via Autopsy or Transplant vs That Determined by CT Scan
Description
the primary outcome was evidence of existing tumor on pathologic review of the liver at the time or transplant or autopsy within the 18 month observational period. This outcome was compared to the CT HCC detection.
Time Frame
18 months after start of therapy
Title
Remote Tumor Occurrence Rates
Description
remote tumor occurrence rate is defined as a new intrahepatic tumor that developed remote from the ablation site within the 18 month period
Time Frame
18 months after start of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald D. Dodd, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Study Chair
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMASS Memorial Cancer Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Rhode Island Hospital Comprehensive Cancer Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Scott and White Cancer Institute
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.gov/ct2/show/NCT00132041
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

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