Cryosurgery in Treating Patients With Liver Cancer or Liver Metastases

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00002655
First received: November 1, 1999
Last updated: July 19, 2013
Last verified: July 2013
  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.


Condition Intervention Phase
Liver Cancer
Metastatic Cancer
Procedure: cryosurgery
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Cryosurgical Destruction of Surgically Incurable Liver Tumors

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Study Start Date: March 1995
Study Completion Date: September 1999
Primary Completion Date: September 1999 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002655

Locations
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Study Chair: Greg V. Stiegmann, MD University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00002655     History of Changes
Other Study ID Numbers: 93-0092.cc, NCI-V95-0657
Study First Received: November 1, 1999
Last Updated: July 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
liver metastases

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014