Clinical trial NCT00019604: Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
Official title: The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Liver Cancer
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
liver metastases
unspecified adult solid tumor, protocol specific
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 9 years, 9 months
measure: Tumor Blood Flow
timeFrame: Baseline, 3 months, and 6 months following treatment
measure: Tumor Vascular Density
timeFrame: Baseline, 3 months, and 6 months following treatment
measure: Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)
timeFrame: Baseline, 6 weeks, 3 months, and 6 months following treatment
measure: Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)
timeFrame: Baseline, 6 weeks, 3 months, and 6 months following treatment
measure: Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies
timeFrame: Baseline, 6 weeks, 3 months, and 6 months following treatment
measure: Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers
timeFrame: Baseline, 6 weeks, 3 months, and 6 months following treatment
measure: Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms
timeFrame: Baseline, 6 weeks, 3 months, and 6 months following treatment
measure: Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)
timeFrame: Baseline, 6 weeks, 3 months, and 6 months following treatment
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
state: Maryland
Study officials:
affiliation: National Cancer Institute, National Institutes of Health
name: Steven A Libutti, MD
role: PRINCIPAL_INVESTIGATOR
References: