Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer

This study has been terminated.
(Principal investigator left the institution.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Caryn Steakley, R.N., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00019604
First received: July 11, 2001
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have unresectable primary or metastatic liver cancer.


Condition Intervention Phase
Liver Cancer
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: computed tomography
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Procedure: radiofrequency ablation
Procedure: radionuclide imaging
Procedure: ultrasound imaging
Radiation: fludeoxyglucose F 18 (FDG-PET)
Radiation: gadopentetate dimeglumine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Response [ Time Frame: unknown ] [ Designated as safety issue: No ]
    Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared tot eh pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 9 years, 9 months ] [ Designated as safety issue: Yes ]
    Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.


Enrollment: 44
Study Start Date: August 1998
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiofrequency ablation in liver cancer
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Procedure: computed tomography
Scan to assess the effects of ablation.
Procedure: magnetic resonance imaging
Imaging used to assess the effects of this ablative therapy on tumor vascular density.
Procedure: positron emission tomography
Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.
Procedure: radiofrequency ablation
Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization.
Procedure: radionuclide imaging
Imaging following injection of a radioactive material.
Procedure: ultrasound imaging
An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.
Radiation: fludeoxyglucose F 18 (FDG-PET)
FDG PET scans rely on metabolic changes to evaluate response to therapy.
Radiation: gadopentetate dimeglumine
Food and Drug Administration approved contrast agent.

Detailed Description:

OBJECTIVES:

  • Evaluate the nature and duration of response of patients with primary or metastatic liver neoplasms, who are not candidates for surgical resection, treated with radiofrequency interstitial tissue ablation.
  • Evaluate the ability of dynamic magnetic resonance imaging (MRI) to assess the effects of this therapy on tumor blood flow and tumor vascular density in these patients.
  • Determine the ability of positron emission tomography with fludeoxyglucose F 18 (FDG-PET) to monitor response after treatment with this therapy in these patients.
  • Compare FDG-PET results with computed tomography (CT) scan, biopsy, and serum marker results in patients treated with this therapy.
  • Compare the performance of FDG-PET with CT scan and MRI, in terms of their ability to assess the efficacy of this therapy in these patients.

OUTLINE: Lesions are targeted by ultrasound and then radiofrequency ablation needles are inserted into the lesions and heated to a target temperature greater than 60 degrees C for 15 minutes, though exposure time may vary depending on temperatures achieved. To achieve a 1 cm margin of ablated tissue around each lesion, multiple ablation courses may be performed, depending on the size of the lesions and the time required to complete the treatment.

Patients undergo magnetic resonance imaging with gadopentetate dimeglumine contrast, CT scan, ultrasound, and positron emission tomography with fludeoxyglucose F 18 at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years.

Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years or until evidence of recurrence.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study within 6 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary or metastatic liver lesions

    • Not a candidate for surgical resection
  • Must have six or fewer lesions and no single lesion greater than 7 cm in diameter
  • Extrahepatic disease allowed

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Platelet count at least 50,000/mm^3
  • Prothrombin time (PT) or partial thromboplastin time (PTT) no greater than 1.5 times control (except for therapeutically anticoagulated nonrelated medical conditions [e.g., atrial fibrillation])

Hepatic:

  • Bilirubin no greater than 3.0 mg/dL

Renal:

  • Creatinine no greater than 2.5 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices
  • No known uncontrollable serious reactions (e.g., anaphylaxis) to contrast agents used in this study
  • Weight less than 136 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • Concurrent systemic therapy for extrahepatic disease is allowed only if begun prior to radiofrequency ablation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019604

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: Steven A Libutti, MD National Cancer Institute, National Institutes of Health
  More Information

No publications provided

Responsible Party: Caryn Steakley, R.N., Principal Investigator, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00019604     History of Changes
Obsolete Identifiers: NCT00001795
Other Study ID Numbers: 990025, 99-C-0025, CDR0000066875
Study First Received: July 11, 2001
Results First Received: April 1, 2014
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
liver metastases
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Fluorodeoxyglucose F18
Gadobenic acid
Gadolinium DTPA
Contrast Media
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals

ClinicalTrials.gov processed this record on October 21, 2014