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

NCT ID: NCT00019604

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31
• Study Completion Date: 2009-01-31

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 computed tomography (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.

Conditions

Liver Cancer; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiofrequency ablation in liver cancer

This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.

Group Type: EXPERIMENTAL

computed tomography

Intervention Type: PROCEDURE

Scan to assess the effects of ablation.

magnetic resonance imaging

Intervention Type: PROCEDURE

Imaging used to assess the effects of this ablative therapy on tumor vascular density.

positron emission tomography

Intervention Type: PROCEDURE

Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.

radiofrequency ablation

Intervention Type: PROCEDURE

Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization.

radionuclide imaging

Intervention Type: PROCEDURE

Imaging following injection of a radioactive material.

ultrasound imaging

Intervention Type: PROCEDURE

An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.

fludeoxyglucose F 18 (FDG-PET)

Intervention Type: RADIATION

FDG PET scans rely on metabolic changes to evaluate response to therapy.

gadopentetate dimeglumine

Intervention Type: RADIATION

Food and Drug Administration approved contrast agent.

Interventions

computed tomography

Scan to assess the effects of ablation.

Intervention Type: PROCEDURE

magnetic resonance imaging

Imaging used to assess the effects of this ablative therapy on tumor vascular density.

Intervention Type: PROCEDURE

positron emission tomography

Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.

Intervention Type: PROCEDURE

radiofrequency ablation

Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization.

Intervention Type: PROCEDURE

radionuclide imaging

Imaging following injection of a radioactive material.

Intervention Type: PROCEDURE

ultrasound imaging

An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.

Intervention Type: PROCEDURE

fludeoxyglucose F 18 (FDG-PET)

FDG PET scans rely on metabolic changes to evaluate response to therapy.

Intervention Type: RADIATION

gadopentetate dimeglumine

Food and Drug Administration approved contrast agent.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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:

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Platelet count at least 50,000/mm^3
• Prothrombin time (PT) or partial thromboplastin time (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Responsible Party

Caryn Steakley, R.N.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven A Libutti, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, National Institutes of Health

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

99-C-0025

Identifier Type: -

Identifier Source: secondary_id

CDR0000066875

Identifier Type: -

Identifier Source: secondary_id

990025

Identifier Type: -

Identifier Source: org_study_id

NCT00001795

Identifier Type: -

Identifier Source: nct_alias