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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019604 |
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 Radiation: gadopentetate dimeglumine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms |
Estimated Enrollment: | 58 |
Study Start Date: | August 1998 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary or metastatic liver lesions
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Steven K. Libutti, MD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000066875, NCI-99-C-0025 |
Study First Received: | July 11, 2001 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00019604 History of Changes |
Health Authority: | United States: Food and Drug Administration |
localized unresectable adult primary liver cancer recurrent adult primary liver cancer liver metastases unspecified adult solid tumor, protocol specific |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms |
Neoplasm Metastasis Gastrointestinal Neoplasms Recurrence |
Liver Neoplasms Neoplastic Processes Liver Diseases Neoplasms Pathologic Processes |
Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Neoplasm Metastasis |