©2022 Stanford Medicine
Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma
Not Recruiting
Trial ID: NCT01327521
Purpose
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.
Official Title
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma
Stanford Investigator(s)
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
Brendan C. Visser, MD
Professor of Surgery (General Surgery)
Samuel So, MD
Lui Hac Minh Professor in the School of Medicine
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Daniel Sze, MD, PhD
Professor of Radiology (Interventional Radiology)
Nishita Kothary, MD
Professor of Radiology (Interventional Radiology)
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
Intervention(s):
device: SMANCS
drug: CT Contrast
drug: doxorubicin
drug: Epirubicin
drug: 5-fluorouracil
drug: Mitomycin C
drug: Gemcitabine
drug: Cisplatin
device: CyberKnife
procedure: TACE
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Laurie Ann Columbo
6507360792