Cryosurgery in Treating Patients With Liver Cancer or Liver Metastases

Phase 2

Completed

• Conditions: Liver Cancer; Metastatic Cancer

• Registration Number: NCT00002655
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1995-03
• Primary Completion: 1999-09
• Study Completion: 1999-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-08-10
• Study First Posted: 2004-08-11
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-19
• Last Update Posted: 2013-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Colorado Cancer Center; 🇺🇸 Denver, Colorado, United States