Brief Summary

RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have unresectable primary or metastatic liver cancer.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Aug 1998

Longer than P75 for phase_2

Geographic Reach

1 country

1 active site

Status

terminated

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

10.4 years study duration

Study Start

First participant enrolled

August 1, 1998

Completed

2.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed

1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed

5.4 years until next milestone

Results Posted

Study results publicly available

June 12, 2014

Completed

Last Updated

February 3, 2017

Status Verified

December 1, 2016

Enrollment Period

10.4 years

First QC Date

July 11, 2001

Results QC Date

April 1, 2014

Last Update Submit

December 7, 2016

Conditions

Liver Cancer Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific

Keywords

localized unresectable adult primary liver cancerrecurrent adult primary liver cancerliver metastasesunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

Response
Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.

Secondary Outcomes (9)

Number of Participants With Adverse Events
9 years, 9 months
Tumor Blood Flow
Baseline, 3 months, and 6 months following treatment
Tumor Vascular Density
Baseline, 3 months, and 6 months following treatment
Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)
Baseline, 6 weeks, 3 months, and 6 months following treatment
Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)
Baseline, 6 weeks, 3 months, and 6 months following treatment
+4 more secondary outcomes

Study Arms (1)

Radiofrequency ablation in liver cancer

EXPERIMENTAL

This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.

Procedure: computed tomographyProcedure: magnetic resonance imagingProcedure: positron emission tomographyProcedure: radiofrequency ablationProcedure: radionuclide imagingProcedure: ultrasound imagingRadiation: fludeoxyglucose F 18 (FDG-PET)Radiation: gadopentetate dimeglumine