Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)
This phase II trial studies how effectively radiofrequency ablation prevents recurrence of hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells.
Procedure: radiofrequency ablation
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Radiofrequency Ablation Under Ideal Conditions in Hepatocellular Carcinoma|
- Local recurrence, defined as the recurrence at the size of original tumor [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Local recurrence will be summarized using descriptive statistics.
- Morbidity and mortality associated with RFA under ideal conditions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]The incidences of surgical complications and procedure-related death will be calculated.
- Overall survival rate [ Time Frame: At 2 years ] [ Designated as safety issue: No ]Kaplan-Meier product limit method will be used to estimate the 2-year overall survival. The median overall survival will also be
- Disease-free survival rate [ Time Frame: At 2 years ] [ Designated as safety issue: Yes ]Kaplan-Meier product limit method will be used to estimate the 2-year disease-free survival. The median disease-free survival will also be estimated.
- Ability of patients who develop recurrence to undergo salvage transplantation [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]At the time of recurrence, the patient is evaluated to see if she/he falls within the Milan criteria; if she/he does, then she/he is considered able to undergo salvage transplantation.
|Study Start Date:||December 2014|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Patients undergo laparoscopic ultrasound followed by RFA.
Procedure: radiofrequency ablation
Undergo RFAProcedure: laparoscopy
Undergo laparoscopic ultrasound
|Contact: Steven Strasberg, M.D.||firstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Not yet recruiting|
|St. Louis, Missouri, United States, 63122|
|Contact: Steven Strasberg, M.D. 314-362-7147 email@example.com|
|Principal Investigator: Steven Strasberg, M.D.|
|Sub-Investigator: William Chapman, M.D.|
|Sub-Investigator: Jeffrey Crippin, M.D.|
|Sub-Investigator: Marie Majella Doyle, M.D.|
|Sub-Investigator: J. Christopher Eagon, M.D.|
|Sub-Investigator: Ryan Fields, M.D.|
|Sub-Investigator: William Hawkins, M.D.|
|Sub-Investigator: Thomas Kerr, M.D., Ph.D.|
|Sub-Investigator: Kevin Korenblat, M.D.|
|Sub-Investigator: David Linehan, M.D.|
|Sub-Investigator: Mauricio Lisker-Melman, M.D.|
|Sub-Investigator: Jeffrey Lowell, M.D.|
|Sub-Investigator: Brent Matthews, M.D.|
|Sub-Investigator: William Middleton, M.D.|
|Sub-Investigator: Vamsi Narra, M.D.|
|Sub-Investigator: Joel Picus, M.D.|
|Sub-Investigator: Steven Sorscher, M.D.|
|Sub-Investigator: Rama Suresh, M.D.|
|Sub-Investigator: Benjamin Tan, M.D.|
|Sub-Investigator: Sharlene Teefey, M.D.|
|Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D.|
|Principal Investigator:||Steven Strasberg, M.D.||Washington University School of Medicine|