AzTrials
AzTrials

Liver CancerACRIN-6673NCT00132041

Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

A study testing radiofrequency ablation in people with Liver Cancer, run by American College of Radiology Imaging Network at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Liver Cancer
What is being tested?
radiofrequency ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
18 sitesUnited States
Study dates
Dec 2005to Nov 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

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

    Chapel Hill, North Carolina, 27599-7295

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Scott and White Cancer Institute

    Temple, Texas, 76508

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients

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.

Read the 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.

Conditions
Liver Cancer
Being tested
radiofrequency ablation
Keywords
adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer
Medical subject headings
Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiofrequency ablationDevice

    Also called RFA

Study groups in NCT00132041
Study groupRoleWhat they receive
All PatientsOtherpatients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC.
Receives: Device: radiofrequency ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months after start of therapy

Secondary outcomes (7)

  1. 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.

    Measured: 18 months after start of therapy

  2. 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.

    Measured: 18 months after start of therapy

  3. 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

    Measured: 18 months after start of therapy

  4. 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.

    Measured: 18 months after start of therapy

  5. 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.

    Measured: 18 months after start of therapy

  6. 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.

    Measured: 18 months after start of therapy

  7. 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

    Measured: 18 months after start of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionAug 2009
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00132041
Sponsor's protocol ID
CDR0000439446
Other IDs
ACRIN-6673, U01CA080098, U01CA079778
Acronym
ACRIN-6673
Status last verified
Aug 2020
First submitted
16 Aug 2005
Last updated
10 Sep 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing radiofrequency ablation in people with Liver Cancer, run by American College of Radiology Imaging Network at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Successful Control of Disease at 18 Months (time frame: 18 months after start of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00132041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in