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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

November 1, 1999
July 19, 2013
March 1995
September 1999   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002655 on ClinicalTrials.gov Archive Site
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Cryosurgery in Treating Patients With Liver Cancer or Liver Metastases
Cryosurgical Destruction of Surgically Incurable Liver Tumors

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Liver Cancer
  • Metastatic Cancer
Procedure: cryosurgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
September 1999
September 1999   (final data collection date for primary outcome measure)

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

Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002655
93-0092.cc, NCI-V95-0657
Yes
University of Colorado, Denver
University of Colorado, Denver
National Cancer Institute (NCI)
Study Chair: Greg V. Stiegmann, MD University of Colorado, Denver
University of Colorado, Denver
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP