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CRYOSURGICAL DESTRUCTION OF SURGICALLY INCURABLE LIVER TUMORS


Phase 2
21 Years
N/A
Not Enrolling
Both
Liver Cancer, Metastatic Cancer

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Trial Information

CRYOSURGICAL DESTRUCTION OF SURGICALLY INCURABLE LIVER TUMORS


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Greg V. Stiegmann, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Federal Government

Study ID:

CDR0000064197

NCT ID:

NCT00002655

Start Date:

March 1995

Completion Date:

Related Keywords:

  • Liver Cancer
  • Metastatic Cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • liver metastases
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262