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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00019604
• Other study ID #: 990025
• Secondary ID: 99-C-0025CDR0000
• Status: Terminated
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: October 1, 2015
• Start date: August 1998
• Est. completion date: January 2009

Study information

• Verified date: October 2015
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00001795

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• computed tomography
Scan to assess the effects of ablation.
• magnetic resonance imaging
Imaging used to assess the effects of this ablative therapy on tumor vascular density.
• positron emission tomography
Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.
• 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.
• radionuclide imaging
Imaging following injection of a radioactive material.
• ultrasound imaging
An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.

Radiation:
• fludeoxyglucose F 18 (FDG-PET)
FDG PET scans rely on metabolic changes to evaluate response to therapy.
• gadopentetate dimeglumine
Food and Drug Administration approved contrast agent.

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response	Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared tot eh pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.	unknown	No
Secondary	Number of Participants With Adverse Events	Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.	9 years, 9 months	Yes