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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. |
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| Detailed Description | OBJECTIVES:
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. |
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| 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 ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Liver Cancer Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
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| 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 |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 58 | ||||
| Start Date † | August 1998 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| 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 † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | July 11, 2001 | ||||
| Last Updated Date | October 18, 2008 | ||||