Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)

NCT ID: NCT01318200

Last Updated: 2012-02-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2016-02-29

Brief Summary

To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic body radiotherapy in the treatment of patients with locally recurrent hepatocellular carcinoma (HCC) after TACE.

Detailed Description

Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors include alcoholic cirrhosis.

Surgical resection and/or transplantation remain the only curative options. However, more than 80% of patients present with unresectable disease. For these patients with unresectable tumors, a variety of treatment options are available, including transarterial chemoembolization (TACE), radiofrequency ablation (RFA), radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available because of significant improvements in diagnostic imaging and radiation delivery techniques. Although follow-up is limited, results show encouraging local control rates. Some investigators have combined TACE with fractionated conventional radiotherapy as a means of intensifying local therapy, with evidence of efficacy.

TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence rates are high. Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in treating HCC needs to be further defined. Moreover, once patients have recurred after initial TACE, it is unclear if additional TACE will be as effective or if another mode of local therapy such as SBRT would be preferable.

We propose to conduct a multicenter randomized study comparing TACE vs. SBRT using CyberKnife for locally recurrent HCC. Locally recurrent HCC will include lesions that persist, progress or recur minimum 3 months after initial TACE.

Conditions

Recurrent Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CyberKnife SBRT

Group Type: ACTIVE_COMPARATOR

CyberKnife SBRT

Intervention Type: RADIATION

Dose is 45 Gy (15 Gy in 3 fractions) or 36 Gy(12 Gy in 3 fractions). Tumors should receive the higher dose unless normal tissue constraints cannot be met.

Transarterial Chemoembolization

Group Type: ACTIVE_COMPARATOR

Transarterial Chemoembolization

Intervention Type: PROCEDURE

Transarterial Chemoembolization will be given within 12 weeks and up to 3 staged procedures, depending on the architecture of the tumor vasculature.

Interventions

Transarterial Chemoembolization

Transarterial Chemoembolization will be given within 12 weeks and up to 3 staged procedures, depending on the architecture of the tumor vasculature.

Intervention Type: PROCEDURE

CyberKnife SBRT

Dose is 45 Gy (15 Gy in 3 fractions) or 36 Gy(12 Gy in 3 fractions). Tumors should receive the higher dose unless normal tissue constraints cannot be met.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Confirmed hepatocellular carcinoma by one of the following:

1. Histopathology

2. 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

1. 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 contrast liver CT

2. A recent serum AFP must 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 7.5 cm as long as the dose constraints to normal tissue can be met.
• Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix I).
• Patients with liver disease classified as Child Pugh class A/B, if Child's class B, score must be 8 or less.
• Life expectancy >= 6 months
• Age >= 18 years old
• Albumin >= 2.5 g/dL
• Total Bilirubin <= 3 mg/dL
• INR <= 1.5
• Creatinine <= 2.0 mg/dL
• Both men and women and members of all races and ethnic groups are eligible for this study
• 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 tumor
• Prior radiotherapy to the upper abdomen
• Prior RFA to index lesion
• Liver transplant
• Tumors greater than 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Accuray Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert Koong, MD, PhD

Role: STUDY_CHAIR

Stanford Comprehensive Cancer Center

Daniel Chang, MD

Role: STUDY_CHAIR

Stanford Comprehensive Cancer Center

Nishita Kothary, MD

Role: STUDY_CHAIR

Stanford Comprehensive Cancer Center

Locations

Stanford Comprehensive Cancer Center

Stanford, California, United States

Countries

United States

Related Links

http://www.cyberknife.com

Information on CyberKnife

http://www.accuray.com

Sponsor website

Other Identifiers

ACCH001.0

Identifier Type: -

Identifier Source: org_study_id