Trial Outcomes & Findings for Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer (NCT NCT00019604)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

44 participants

Results posted on

2017-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Radiofrequency Ablation in Liver Cancer 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.
Overall Study STARTED	44
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiofrequency Ablation in Liver Cancer 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.
Overall Study Death	1
Overall Study Progressive disease	23
Overall Study Refused treatment	1
Overall Study Carcinoid tumor, not treatable	1
Overall Study Going to have liver transplant	1
Overall Study Move to a different study	1
Overall Study Non compliant on systemic CH	1
Overall Study Non compliant	1
Overall Study Resectable disease	1
Overall Study Started new chemo regimen	1
Overall Study Pt going to immunotherapy study	1
Overall Study Too much disease	1
Overall Study Unable to evaluate	1
Overall Study Details for other not available	4

Baseline Characteristics

Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiofrequency Ablation in Liver Cancer n=44 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	59.18 years STANDARD_DEVIATION 13.19 • n=5 Participants
Gender Female	21 Participants n=5 Participants
Gender Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	44 Participants n=5 Participants

PRIMARY outcome

Population: The time frame for this outcome measure is unknown; the investigator left the institution and there is no available data. We only have access available on 23 participants. We cannot comment on the others or verify because we do not have the data.

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.

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation in Liver Cancer n=23 Participants 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.
Response Complete Response	0 Participants
Response Partial Response	0 Participants
Response Minor Response	0 Participants
Response Stable Disease	0 Participants
Response Progressive Disease	23 Participants

SECONDARY outcome

Timeframe: 9 years, 9 months

Population: NA is entered for the total number of participants with adverse events because it is unknown. Adverse event data is available but the format is uninterpretable.

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.