Cryosurgery in Treating Patients With Liver Cancer or Liver Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1995-03-31

Study Completion Date

1999-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Cancer Metastatic Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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cryosurgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No