Trial Outcomes & Findings for Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis (NCT NCT00132041)

NCT ID: NCT00132041

Last Updated: 2020-09-10

Results Overview

Outcome is positive (success) if alive and no disease is observed by CT at 18 months post start of therapy Outcome is negative if the patient was deceased or disease was observed by CT at 18 months post start of therapy Success rate it the fraction of eligible patients who were alive and disease free at 18 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: 18 months after start of therapy
• Results posted on: 2020-09-10

Participant Flow

Participant milestones

Measure	All Patients patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Baseline STARTED	51
Baseline Eligible	45
Baseline COMPLETED	45
Baseline NOT COMPLETED	6
3 Months Post Ablation STARTED	45
3 Months Post Ablation COMPLETED	42
3 Months Post Ablation NOT COMPLETED	3
6 Months Post Ablation STARTED	42
6 Months Post Ablation COMPLETED	32
6 Months Post Ablation NOT COMPLETED	10
9 Months Post Ablation STARTED	32
9 Months Post Ablation COMPLETED	30
9 Months Post Ablation NOT COMPLETED	2
12 Months Post Ablation STARTED	30
12 Months Post Ablation COMPLETED	26
12 Months Post Ablation NOT COMPLETED	4
15 Months Post Ablation STARTED	26
15 Months Post Ablation COMPLETED	18
15 Months Post Ablation NOT COMPLETED	8
18 Months Post Ablation STARTED	18
18 Months Post Ablation COMPLETED	12
18 Months Post Ablation NOT COMPLETED	6

Reasons for withdrawal

Measure	All Patients patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Baseline Ineligible	6
3 Months Post Ablation Transplant	1
3 Months Post Ablation Non-Protocol Treatment	2
6 Months Post Ablation Withdrawal by Subject	2
6 Months Post Ablation Death	2
6 Months Post Ablation Transplant	6
9 Months Post Ablation Death	1
9 Months Post Ablation Transplant	1
12 Months Post Ablation Withdrawal by Subject	1
12 Months Post Ablation Death	1
12 Months Post Ablation Transplant	1
12 Months Post Ablation non-protocol Treatment	1
15 Months Post Ablation Withdrawal by Subject	1
15 Months Post Ablation Death	1
15 Months Post Ablation Transplant	5
15 Months Post Ablation Non-Protocol Treatment	1
18 Months Post Ablation Withdrawal by Subject	1
18 Months Post Ablation Transplant	1
18 Months Post Ablation Non-Protocol Treatment	3
18 Months Post Ablation ExtraHepatic tumor	1

Baseline Characteristics

Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

Baseline characteristics by cohort

Measure	All Patients n=45 Participants patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Age, Continuous	62 years n=93 Participants
Sex: Female, Male Female	14 Participants n=93 Participants
Sex: Female, Male Male	31 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	31 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=93 Participants

PRIMARY outcome

Timeframe: 18 months after start of therapy

Population: Patients not reaching 18mo were considered failures

Outcome is positive (success) if alive and no disease is observed by CT at 18 months post start of therapy Outcome is negative if the patient was deceased or disease was observed by CT at 18 months post start of therapy Success rate it the fraction of eligible patients who were alive and disease free at 18 months.

Outcome measures

Measure	Eligible Patients n=45 Participants patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.	Repetitive Ablation patients with cirrhosis undergoing repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Proportion of Participants With Successful Control of Disease at 18 Months	.18 proportion of participants Interval 0.08 to 0.321	—

SECONDARY outcome

Timeframe: 18 months after start of therapy

Population: of the 45 participants, 35 had single ablate therapy while 10 received multiple RFA sessions.

this outcome measures the impact of Solitary vs repetitive radiofrequency ablation on success.

Success is defined as the number of patients centrally determined to be alive and tumor-free 18 months after start of therapy, corrected for repetitive RFA.

Outcome measures

Measure	Eligible Patients n=35 Participants patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.	Repetitive Ablation n=10 Participants patients with cirrhosis undergoing repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation Success	5 Participants	3 Participants
Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation Failure	30 Participants	7 Participants

SECONDARY outcome

Timeframe: 18 months after start of therapy

Population: 8 participants has successful control at 18mo; 37 participants did not.

Outcome is positive (success) if alive and no disease is observed by CT at 18 months post start of therapy Outcome is negative if the patient was deceased or disease was observed by CT at 18 months post start of therapy Success rate it the fraction of eligible patients who were alive and disease free at 18 months. Tumor size is a continuous variable as measured at imaging.

Outcome measures

Measure	Eligible Patients n=45 Participants patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.	Repetitive Ablation patients with cirrhosis undergoing repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Effect of Tumor Size on Successful Control of Disease at 18 Months Successful Control mean size	2.80 centimeters Standard Deviation 0.85	—
Effect of Tumor Size on Successful Control of Disease at 18 Months Failure mean size	3.32 centimeters Standard Deviation 1.26	—

SECONDARY outcome

Timeframe: 18 months after start of therapy

local tumor control rate is defined as a tumor that was ablated and was not seen again within the 18 month period

Outcome measures

Measure	Eligible Patients n=45 Participants patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.	Repetitive Ablation patients with cirrhosis undergoing repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Local Tumor Recurrence (Control) Rates	0.51 percentage recurring Interval 0.358 to 0.663	—

SECONDARY outcome

Timeframe: 18 months after start of therapy

Population: local tumor control rate (No Recurrence) is defined as a tumor that was ablated and was not seen again

Lesion level local control is defined as a success if a tumor is ablated and does not recur in 18 mo.

Outcome measures

Measure	Eligible Patients n=60 lesions patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.	Repetitive Ablation patients with cirrhosis undergoing repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Impact of Tumor Size on Local Control Rates No Recurrance	2.4833 cm Standard Deviation 0.999	—
Impact of Tumor Size on Local Control Rates Recurrance	2.9417 cm Standard Deviation 0.8622	—

SECONDARY outcome

Timeframe: 18 months after start of therapy

Whether or not extrahepatic tumors were seen at 18months post ablation will be compared with the number of RFA sessions.

Outcome measures

Measure	Eligible Patients n=6 Participants patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.	Repetitive Ablation n=39 Participants patients with cirrhosis undergoing repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Development of Extra-hepatic Tumor 1-RFA	2 Participants	25 Participants
Development of Extra-hepatic Tumor Multiple RFA	4 Participants	14 Participants

SECONDARY outcome

Timeframe: 18 months after start of therapy

Population: 14 cases (13 transplanted cases and 1 deceased case) had pathology available for review, representing 16 specimens (12 tumors in 14 livers))

the primary outcome was evidence of existing tumor on pathologic review of the liver at the time or transplant or autopsy within the 18 month observational period. This outcome was compared to the CT HCC detection.

Outcome measures

Measure	Eligible Patients n=4 specimen patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.	Repetitive Ablation n=12 specimen patients with cirrhosis undergoing repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Local Tumor Eradication Rate by Examination of Liver Via Autopsy or Transplant vs That Determined by CT Scan CT negative (not seen)	3 specimen	11 specimen
Local Tumor Eradication Rate by Examination of Liver Via Autopsy or Transplant vs That Determined by CT Scan CT Positive (seen)	1 specimen	1 specimen

SECONDARY outcome

Timeframe: 18 months after start of therapy

remote tumor occurrence rate is defined as a new intrahepatic tumor that developed remote from the ablation site within the 18 month period

Outcome measures

Measure	Eligible Patients n=45 Participants patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.	Repetitive Ablation patients with cirrhosis undergoing repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Remote Tumor Occurrence Rates	0.53 percent occuring Interval 0.379 to 0.683	—

POST_HOC outcome

Timeframe: 18 months after start of therapy

Outcome is positive (success) if the participant received a liver transplant or no diseaseis was observed by CT at 18 months after start of therapy Success rate it the fraction of eligible patients who are successes at 18 months.

Outcome measures

Measure	Eligible Patients n=45 Participants patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.	Repetitive Ablation patients with cirrhosis undergoing repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
Rate of Successful Control of Disease at 18 Months, Including Transplants	0.51 proportion of successes to eligible Interval 0.358 to 0.663	—

Adverse Events

All Patients

Serious events: 5 serious events

Other events: 26 other events

Deaths: 3 deaths

Serious adverse events

Measure	All Patients n=45 participants at risk patients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC. radiofrequency ablation
Hepatobiliary disorders Death	2.2% 1/45 • Number of events 1 • from initial ablation to 18 months
Surgical and medical procedures hemorrage with ablation/ procedure	2.2% 1/45 • Number of events 1 • from initial ablation to 18 months
Hepatobiliary disorders Hematoma	2.2% 1/45 • Number of events 1 • from initial ablation to 18 months
Hepatobiliary disorders renal failure	2.2% 1/45 • Number of events 1 • from initial ablation to 18 months

Other adverse events

Measure	All Patients n=45 participants at risk patients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC. radiofrequency ablation
Skin and subcutaneous tissue disorders Bruising	2.2% 1/45 • Number of events 1 • from initial ablation to 18 months
General disorders Chills	2.2% 1/45 • Number of events 1 • from initial ablation to 18 months
Blood and lymphatic system disorders Hematoma	2.2% 1/45 • Number of events 1 • from initial ablation to 18 months
Blood and lymphatic system disorders Hemorrhage with surgery	2.2% 1/45 • Number of events 1 • from initial ablation to 18 months
Metabolism and nutrition disorders Metabolic/Lab - Other	11.1% 5/45 • Number of events 6 • from initial ablation to 18 months
General disorders Pain	15.6% 7/45 • Number of events 9 • from initial ablation to 18 months
Respiratory, thoracic and mediastinal disorders pneumothorax	4.4% 2/45 • Number of events 2 • from initial ablation to 18 months

Additional Information

Donna Harfeil, Director of Protocol Management

American College of Radiology Imaging Network

Phone: 215-717-2765

Email: Donna Hartfeil <dhartfeil@acr.org>

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place