NCT00002655

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1995

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1995

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1999

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

August 11, 2004

Completed
Last Updated

July 22, 2013

Status Verified

July 1, 2013

Enrollment Period

4.5 years

First QC Date

November 1, 1999

Last Update Submit

July 19, 2013

Conditions

Liver CancerMetastatic Cancer

Keywords

localized unresectable adult primary liver cancerrecurrent adult primary liver cancerliver metastases

Interventions

cryosurgeryPROCEDURE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsNeoplasm MetastasisCarcinoma, Hepatocellular

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Greg V. Stiegmann, MD

    University of Colorado, Denver

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 11, 2004

Study Start

March 1, 1995

Primary Completion

September 1, 1999

Study Completion

September 1, 1999

Last Updated

July 22, 2013

Record last verified: 2013-07

Locations

US(1)