Purpose:
RATIONALE: Cryosurgery kills cancer cells by freezing them during surgery.
PURPOSE: Phase I/II trial to study the effectiveness of cryosurgery in treating patients
with unresectable primary liver cancer or liver metastases.
Study summary:
OBJECTIVES: I. Assess the safety and efficacy of liquid nitrogen necrosis of liver lesions
using a commercially available intraoperative cryosurgical system, with placement of the
cryoprobe and subsequent monitoring by high-resolution ultrasound. II. Use this technique on
selected patients with surgically unresectable metastatic or primary liver cancer whose
disease appears confined to the liver and who are potentially curable if all tumor in the
liver can be destroyed. III. Quantitate the quality and duration of survival, identify
recurrence of hepatic malignant disease, and identify any morbidity from the procedure.
OUTLINE: Cryosurgery. Liquid nitrogen freezing of tumor using a cryoprobe placed and
maintained under ultrasound guidance.
PROJECTED ACCRUAL: 50 patients will be treated.
Criteria:
DISEASE CHARACTERISTICS: Biopsy-proven metastatic or primary malignant disease of the
liver No extrahepatic regional or distant metastases No primary tumors commonly associated
with local spread or metastases to other sites, e.g.: Gastric cancer Pancreatic cancer
Breast cancer Lung cancer Liver lesions considered unresectable because of location in
relation to major vascular structures or involvement of multiple hepatic segments Tumor
extent and location such that cryosurgery expected to destroy all tumor and render patient
disease-free Tumor volume no greater than 50% of total hepatic volume on CT No more than
12 lesions
PATIENT CHARACTERISTICS: Age: Over 21 Other: Overall health permitting safe laparotomy
Blood/body fluid analyses and imaging/exams for tumor measurement within 1 month prior to
registration
PRIOR CONCURRENT THERAPY: Prior liver resection, radiotherapy, or chemotherapy allowed