Cryosurgery in Treating Patients With Liver Cancer or Liver Metastases

Metastatic Cancer Clinical Trial

Official title:

Cryosurgical Destruction of Surgically Incurable Liver Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002655
• Other study ID #: 93-0092.cc
• Secondary ID: NCI-V95-0657
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 19, 2013
• Start date: March 1995
• Est. completion date: September 1999

Study information

• Verified date: July 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 1999
• Est. primary completion date: September 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• cryosurgery

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,