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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019604
  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
Drug: fludeoxyglucose F 18
Drug: gadopentetate dimeglumine
Procedure: computed tomography
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Procedure: radiofrequency ablation
Procedure: radionuclide imaging
Procedure: ultrasound imaging
Phase II

MedlinePlus related topics:   CT Scans    Cancer    Liver Cancer    MRI Scans    Nuclear Scans   

Drug Information available for:   Fluorodeoxyglucose F18    Gadolinium dtpa   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Nature and duration of response [ Designated as safety issue: No ]
  • Treatment effects [ Designated as safety issue: No ]
  • Response as measured by positron emission tomography with fludeoxyglucose F 18 (FDG-PET) after treatment [ Designated as safety issue: No ]
  • Comparison of FDG-PET results with CT scan, biopsy, and serum marker results [ Designated as safety issue: No ]
  • Comparison of FDG-PET performance with CT scan and MRI performance in assessing efficacy of study treatment [ Designated as safety issue: No ]

Estimated Enrollment:   58
Study Start Date:   August 1998

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 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:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Platelet count at least 50,000/mm^3
  • PT or 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

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
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     Steven K. Libutti, MD     NCI - Surgery Branch    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066875, NCI-99-C-0025
First Received:   July 11, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00019604
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
localized unresectable adult primary liver cancer  
recurrent adult primary liver cancer  
liver metastases  
unspecified adult solid tumor, protocol specific  

Study placed in the following topic categories:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Liver neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Recurrence
Hepatocellular carcinoma

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on October 31, 2008




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