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

This study is ongoing, but not recruiting participants.
Study NCT00019604.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
Official Title  The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms
Brief Summary

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.

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure  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 ]
Secondary Outcome Measure 
Condition  Liver Cancer
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Intervention  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
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  58
Start Date  August 1998
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00019604
Organization ID CDR0000066875
Secondary IDs †† NCI-99-C-0025
Study Sponsor  NCI - Center for Cancer Research-Medical Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Steven K. Libutti, MD     NCI - Surgery Branch    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2008
First Received Date  July 11, 2001
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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