Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01327521
• Other study ID #: HEP0030
• Secondary ID: ACCH001.0SU-0505
• Status: Withdrawn
• Phase: Phase 3
• First received: March 30, 2011
• Last updated: June 7, 2012
• Start date: February 2011

Study information

• Verified date: June 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

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

Secondary Objectives:

1. To determine the progression-free survival of TACE vs. CyberKnife SBRT

2. To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC

3. To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment of recurrent HCC.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Device:
• CyberKnife
Standard of Care

Procedure:
• TACE
Standard of Care

Drug:
• CT Contrast
Standard of Care
• doxorubicin
Standard of Care
• Epirubicin
Standard of Care
• 5-fluorouracil
Standard of Care
• Mitomycin C
Standard of Care
• Gemcitabine
Standard of Care
• Cisplatin
Standard of Care

Device:
• SMANCS
Standard of Care

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Albert Koong	Accuray Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from local progression at 6 months and 12 months		6 months and 12 months	No
Secondary	Progression-free survival		at 6, 12 and 18 months	No
Secondary	Overall survival		at 6, 12, 18 months and up to 3 years	No
Secondary	Serum AFP levels		1 month, 3 months, 6 months, 12 months and 18 months	No