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A Phase II Study of Radiofrequency Ablation of Unresectable Liver Tumors


Phase 2
N/A
N/A
Not Enrolling
Both
Liver Cancer, Metastatic Cancer

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Trial Information

A Phase II Study of Radiofrequency Ablation of Unresectable Liver Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of Radiofrequency Ablation in Patients with Primary or Metastatic Liver Cancer

Outcome Time Frame:

1 Month

Safety Issue:

No

Principal Investigator

Steven A. Curley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

ID97-328

NCT ID:

NCT00004136

Start Date:

November 1999

Completion Date:

January 2006

Related Keywords:

  • Liver Cancer
  • Metastatic Cancer
  • 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
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009