Cryosurgery in Treating Patients With Liver Cancer or Liver Metastases
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Cryosurgical Destruction of Surgically Incurable Liver Tumors|
|Study Start Date:||March 1995|
|Study Completion Date:||September 1999|
|Primary Completion Date:||September 1999 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002655
|United States, Colorado|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80262|
|Study Chair:||Greg V. Stiegmann, MD||University of Colorado, Denver|