Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
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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 Radiation: gadopentetate dimeglumine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms |
- 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 ]
| Enrollment: | 58 |
| Study Start Date: | August 1998 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
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 |
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| 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 |
More Information
No publications provided
| Responsible Party: | Steven A. Libutti, M.D./National Cancer Institute, National Institutes of Health |
| 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 |
| Last Updated: | May 11, 2012 |
| 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 Neoplasms Neoplasms, Second Primary Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013