Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)

NCT01669668 | Withdrawn Phase 2

• 1 other identifier: 201207113
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Local recurrence, defined as the recurrence at the size of original tumor

  Local recurrence will be summarized using descriptive statistics.

  Up to 2 years

Secondary Outcomes (4)

• Morbidity and mortality associated with RFA under ideal conditions

  30 days

• Overall survival rate

  At 2 years

• Disease-free survival rate

  At 2 years

• Ability of patients who develop recurrence to undergo salvage transplantation

  Up to 2 years

Study Arms (1)

RFA

EXPERIMENTAL

Patients undergo laparoscopic ultrasound followed by RFA.

Procedure: radiofrequency ablation; Procedure: laparoscopy

Interventions

radiofrequency ablation PROCEDURE

Undergo RFA

RFA

laparoscopy PROCEDURE

Undergo laparoscopic ultrasound

RFA

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven HCC or unambiguous radiologic findings consistent with HCC (\> 1 cm tumor with arterial hypervascularity and venous or delayed phase washout) in patients with underlying liver disease.
• Disease must be considered unresectable (as defined by protocol).
• Age between 18 and 69 (inclusive).
• Karnofsky performance status of ≥ 80%
• Normal organ and marrow function as defined below:
• leukocytes ≥3,000/mcL
• absolute neutrophil count ≥1,500/mcL
• platelets \>100,000/mcL
• total bilirubin \<2.0 mg/dL
• AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
• creatinine within normal institutional limits OR
• creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• Presence of ≤ 3 tumors, all of which are ≤ 3 cm in size. This will be determined preoperatively and confirmed by intraoperative ultrasound.
• Liver function of Child-Pugh class A or B
• Tumor(s) must be more than 2 cm away from of major biliary duct or major blood vessel defined as the main portal vein and its right and left primary branches and the first 1 cm of the secondary branches of the common hepatic duct and its right and left primary branches or the first 1 cm of its secondary branches.

You may not qualify if:

• Hepatic tumor(s) with satellite lesions. A satellite lesion is defined as a tumor which is within 2 cm of the tumor being assessed for treatment and which has a diameter of less than 33% of the diameter of the tumor being assessed for treatment.
• Evidence of metastatic/extrahepatic disease based on abdominal and chest CT performed within 4 weeks of the procedure.
• Extrahepatic disease upon laparoscopy performed at the time of RFA. If extrahepatic disease is discovered at this laparoscopy, RFA will not be performed, and the patient will be considered ineligible for this study and will be replaced.
• Pregnancy. All women of childbearing potential must have a negative pregnancy test prior to enrollment in the study.
• Previous history of HCC or any other non-cutaneous malignancy.
• Patients who are found to be ineligible due to intraoperative findings will be recorded as to the cause of ineligibility. They will not be counted as accrued patients.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation; Laparoscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Study Officials

• Steven Strasberg, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 21, 2012
• Study Start: December 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 16, 2014

Record last verified: 2014-07