Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132041
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2005-08-16
Brief Title:
Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis
Sponsor:
American College of Radiology Imaging Network
Organization:
American College of Radiology Imaging Network
Study Overview
Official Title:
Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACRIN-6673
Brief Summary:
RATIONALE Radiofrequency ablation uses a high-frequency electric current to kill tumor cells CT- MRI- or ultrasound-guided radiofrequency ablation may be an effective treatment for liver cancer and cirrhosis
PURPOSE This phase II trial is studying how well radiofrequency ablation works in treating patients with liver cancer and cirrhosis
PURPOSE This phase II trial is studying how well radiofrequency ablation works in treating patients with liver cancer and cirrhosis
Detailed Description:
OBJECTIVES
Primary
Determine the 18-month successful disease control rate defined as no identifiable liver tumor by CT scan in patients with hepatocellular carcinoma and cirrhosis treated with solitary or repetitive percutaneous radiofrequency ablation RFA
Secondary
Correlate tumor size MELD score and the number of RFA treatments solitary or repetitive with the 18-month successful disease control rate in patients treated with this procedure
Determine the local and remote intrahepatic and extrahepatic tumor recurrence rates in patients treated with this procedure
Correlate local and remote intrahepatic and extrahepatic tumor recurrence rates with the 18-month successful disease control rate in patients treated with this procedure
Correlate tumor size with the local disease control rate in patients treated with this procedure
Correlate solitary or repetitive RFA with or without localregional tumor control with the development of extrahepatic tumor in these patients
Determine the local tumor eradication rate as determined by examination of whole liver specimens or CT scan in patients treated with this procedure
OUTLINE This is a multicenter study Patients are stratified according to hepatic dysfunction using the MELD score 15 vs 15-25 vs 25
Patients undergo placement of an ablation electrode percutaneously into the tumors by CT scan MRI or ultrasound guidance Patients then undergo percutaneous radiofrequency ablation RFA directly to the tumors for 12 minutes Patients undergo CT scan of the liver within 1 week after RFA treatment and then every 3 months for up to 18 months Patients with residual or recurrent intrahepatic tumors detectable on the 3-month or subsequent CT scan undergo repeat RFA as is technically feasible and clinically indicated for up to 15 months after initial RFA treatment
After completion of study treatment patients are followed at 1 day 1 week 1 month and then every 3 months for up to 18 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Determine the 18-month successful disease control rate defined as no identifiable liver tumor by CT scan in patients with hepatocellular carcinoma and cirrhosis treated with solitary or repetitive percutaneous radiofrequency ablation RFA
Secondary
Correlate tumor size MELD score and the number of RFA treatments solitary or repetitive with the 18-month successful disease control rate in patients treated with this procedure
Determine the local and remote intrahepatic and extrahepatic tumor recurrence rates in patients treated with this procedure
Correlate local and remote intrahepatic and extrahepatic tumor recurrence rates with the 18-month successful disease control rate in patients treated with this procedure
Correlate tumor size with the local disease control rate in patients treated with this procedure
Correlate solitary or repetitive RFA with or without localregional tumor control with the development of extrahepatic tumor in these patients
Determine the local tumor eradication rate as determined by examination of whole liver specimens or CT scan in patients treated with this procedure
OUTLINE This is a multicenter study Patients are stratified according to hepatic dysfunction using the MELD score 15 vs 15-25 vs 25
Patients undergo placement of an ablation electrode percutaneously into the tumors by CT scan MRI or ultrasound guidance Patients then undergo percutaneous radiofrequency ablation RFA directly to the tumors for 12 minutes Patients undergo CT scan of the liver within 1 week after RFA treatment and then every 3 months for up to 18 months Patients with residual or recurrent intrahepatic tumors detectable on the 3-month or subsequent CT scan undergo repeat RFA as is technically feasible and clinically indicated for up to 15 months after initial RFA treatment
After completion of study treatment patients are followed at 1 day 1 week 1 month and then every 3 months for up to 18 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACRIN-6673 | OTHER | None | None |
| U01CA080098 | NIH | None | None |
| U01CA079778 | NIH | CIP | httpsreporternihgovquickSearchU01CA079778 |