Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

June 7, 2012 updated by: Albert Koong

International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma

Primary Objective:

To compare the efficacy of TACE vs. CyberKnife SBRT in the treatment of locally recurrent HCC after initial TACE.

Secondary Objectives:

To determine the progression-free survival of TACE vs. CyberKnife SBRT
To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC
To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment of recurrent HCC.

Study Overview

Status

Withdrawn

Conditions

Carcinoma, Hepatocellular

Intervention / Treatment

Study Type

Interventional

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Stanford, California, United States, 94305
    - Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Confirmed hepatocellular carcinoma by one of the following:
- Histopathology
- One radiographic technique that confirms a lesion >=2 cm with arterial enhancement with washout on delayed phase
Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure
Radiographic evidence of persistent, progressive or recurrent disease in an area previously treated with TACE. This evaluation should be determined after 6 weeks of initial TACE
Multi-specialty evaluation whereby the recurrent liver lesion was deemed by both the attending radiation oncologist and interventional radiologist amenable to treatment by the respective modality
- Eligible patients must undergo an IV contrast CT scan of the liver within 6 weeks of enrollment onto the study; a contrast enhanced liver MRI may be substituted for the IV contrast CT of the liver.
- A recent serum AFP must also be obtained within 4 weeks of enrollment.
Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. Multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 7.5cm as long as the dose constraints to normal tissue can be met
Eastern Clinical Oncology Group performance status 0, 1 or 2
Patients with liver disease classified as Child Pugh class A/B; if Child's class B, score must be 8 or less
Albumin >= 2.5 g/dL
Total bilirubin <= 3 mg/dL
INR <= 1.5
Creatinine <= 2.0 mg/dL
Age >= 18 years old
Life expectancy>= 6 months
Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Prior radiation for the recurrent liver tumors
Prior radiotherapy to the upper abdomen
Prior RFA to index lesion
Liver transplant
Tumors >= 7.5 cm in greatest axial dimension
Portal vein thrombus
Large varices within 2 cm of index lesion (seen on cross section imaging)
Contraindication to receiving radiotherapy
Active gastrointestinal bleed within 2 weeks of study enrollment
Ascites refractory to medical therapy
Women who are pregnant
Administration of any systemic chemotherapy within the last 1 month
Presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases
Participation in another concurrent SYSTEMIC treatment protocol
Prior history of malignancy other than HCC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom from local progression at 6 months and 12 months Time Frame: 6 months and 12 months	6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival Time Frame: at 6, 12 and 18 months	at 6, 12 and 18 months
Overall survival Time Frame: at 6, 12, 18 months and up to 3 years	at 6, 12, 18 months and up to 3 years
Serum AFP levels Time Frame: 1 month, 3 months, 6 months, 12 months and 18 months	1 month, 3 months, 6 months, 12 months and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Koong

Collaborators

Accuray Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria