Clinical trial NCT00004136: Heat Therapy in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
Official title: A Phase II Study of Radiofrequency Ablation of Unresectable Liver Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Metastatic Cancer
Keywords: stage III childhood liver cancer
stage IV childhood liver cancer
recurrent childhood liver cancer
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
liver metastases
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-08-20
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Heating tumors to several degrees above body temperature may kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of heat therapy in treating patients who have unresectable primary or metastatic liver cancer.

Detailed description: OBJECTIVES: I. Determine the efficacy of radiofrequency ablation in patients with primary or metastatic liver cancer. II. Determine disease free survival, local recurrence rate in treated lesions as compared to known recurrence rates after hepatic cryoablation, and overall survival in this patient population receiving this regimen.

OUTLINE: Patients undergo laparoscopic or open laparotomy surgical procedure to identify unresectable tumors by ultrasound. Tumors are heated to a target temperature by electrodes for a maximum of 20 minutes. 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 may be retreated if tumor recurs or new disease appears. Patients are followed at 1 month, every 3 months for the first 2 years, every 6 months for next 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 59 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS: Diagnosis of unresectable malignant primary or metastatic liver tumors Tumors are deemed unresectable based on the following factors: 1-10 liver tumors Bilobar liver tumors Location of 1 or more lesions near a major intrahepatic vascular structure (hepatic vein, portal vein, vena cava) Severe cirrhosis to preclude a major liver resection No unresectable extrahepatic disease Prior failure of other therapeutic modalities allowed No more than moderate ascites No hepatic encephalopathy

PATIENT CHARACTERISTICS: Age: Any age Performance status: Zubrod 0-1 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: No severe liver dysfunction (Child's Class C) Bilirubin no greater than 3.0 mg/dL Albumin no greater than 3.0 mg/dL PT no greater than 50% above normal Renal: No renal dysfunction Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No altered mental status No active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics

Primary outcomes:
measure: Efficacy of Radiofrequency Ablation in Patients with Primary or Metastatic Liver Cancer
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Steven A. Curley, MD
role: STUDY_CHAIR
References: