MDACC Study Summary ACRIN06-6673

Study Summary
No. ACRIN06-6673:.......Liver......Kamran Ahrar......Interventional Radiology

Study Summary Title



Study Summary Number:	ACRIN06-6673

Study Title:	MULTICENTER FEASIBILITY STUDY OF PERCUTANEOUS RADIOFREQUENCY ABLATION OF HEPATOCELLULAR CARCINOMA IN CIRRHOTIC PATIENTS

Physician

New Patient Referral



Name:	Kamran Ahrar	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Interventional Radiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-7842 Contact us about clinical trials

General Information



Disease Group:	Liver	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	9 visit over 18 months including the pre procedure, procedure and post procedure follow up

Treatment Agents:	Radiofrequency Ablation	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	1 to 3 nights


Description/ Intervention:	The goal of this clinical research study is to find out what effects (good and/or bad) radiofrequency ablation (RFA) has on patients with liver cancer.

Study Objectives / Outcomes

Primary Objective:

To estimate the proportion of participants undergoing solitary or repetitive percutaneous RFA treatment sessions whose livers have no identifiable tumor by CT scan at 18 months following initiation of therapy.

Secondary Objectives:

Explore the impact of solitary versus repetitive RFA on the primary objective;

2. Explore the impact of tumor size on the primary objective;

3. Evaluate for a possible correlation between the MELD Score and the primary objective;

4. Estimate the local and remote intrahepatic and extrahepatic tumor recurrence rates and their impact on the primary objective;

5. Explore the impact of tumor size on the local control rates;

6. Explore the impact of solitary or repetitive RFA with or without local/regional control on the development of extra-hepatic tumor;

7. Estimate the local tumor eradication rate as determined by examination of whole liver specimens obtained via autopsy or explanation versus that determined by CT scan.

Study Status Information



Study Activation / Registration Date:	06/08/2006

IRB Review and Approval Date:	03/15/2006

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	40

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Participants 18 years and older

2) Biopsy proven cirrhosis, or typical findings of cirrhosis by CT scan which may include parenchymal inhomogeneity, surface nodularity, enlarged left lobe, enlarged caudate lobe, and/or presence of varices;

3) Biopsy proven hepatocellular carcinoma (HCC), or a discrete hepatic tumor(s) as defined by the Barcelona criteria (2 imaging studies showing hypervascular tumor > 2cm, or single imaging study showing hypervascular tumor > 2cm with AFP >/= 400 ng/mL), or a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI) with documented growth of > 1cm in diameter;

4) Hepatic tumor burden meeting the Milan Criteria: 3 or fewer tumors </= 3.0 cm, or a single tumor > 3.0 cm but </= 5 cm in diameter;

5) All identified tumors are deemed treatable by percutaneous RFA by the site PI;

6) All tumors >/= 1 cm from the main, right and left portal veins;

7) All tumors >/= 1 cm from hollow viscera;

8) Performance status 0-2 on Zubrod Performance Scale;

9) Serum creatinine </= 2.0 mg/dl;

10) Study-specific signed informed consent;

11) Not a candidate for surgical resection;

12) No previous or current treatment for HCC by any method (no radiation therapy, chemotherapy, chemoembolization, and cryo-ablation) and agrees not to be treated by these therapies while on this study;

13) Chest and abdominal CT scan within 60 days prior to initial RFA treatment.

Exclusion Criteria:

1) Prior treatment for HCC by any method;

2) Tumor(s) < 1cm from main, right , or left portal veins, or hollow viscera;

3) Hepatic or portal vein tumor invasion;

4) Excessive intrahepatic tumor burden (> 3 hepatic tumors or a tumor > 5cm) ;

5) Tumors untreatable by percutaneous ablation as determined by site PI;

6) Extrahepatic tumor;

7) Uncorrectable coagulopathy;

8) Serum creatinine > 2 mg/dl;

9) Active infection (Symptomatic bacterial and fungal infection – newly diagnosed and/or requiring treatment);

10) Choledocho-enteric anastomosis;

11) Sphincterotomy of duodenal papilla

12) Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).

13) Pregnant women are ineligible because it is unknown what effect RF ablation may have on the developing fetus;

14) Surgical candidate;

15) Unbiopsied tumor(s) failing Barcelona or interval growth criteria;

Links

Registration Number: NCT00399958
Study Information on Clinical Trials Registry (clinicaltrials.gov)