SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

Recruitment & Eligibility

Inclusion Criteria

HCC diagnosis according to the American Association for the Study of Liver Diseases (AASLD) 2010 criteria
Tumor Stage
liver only disease
tumor thrombus at segment is allowed
no extra hepatic metastases
tumor encompassing less than 50% of hepatic volume
previous treatment with Transarterial Chemo Embolization (TACE) - patient must have performed at least 2 sessions of TACE and have signs of viable tumor in CT or MRI performed 30-40 days after last TACE
presence of measurable lesion (at least one lesion that can be measured equal or more than 1 cm in CT or MRI).
Maximum lesion size of 10 cm.
Liver residual volume equal or more than 700cc or 40% of total liver volume
Child-Pugh A or absence of hepatic cirrhosis
absence of encephalopathy or ascitis on clinical exam
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Lab exams:
hemoglobin > or equal 8 mg/dl
neutrophils > or equal 1.200/mm³
platelets > or equal 45.000/mm³
alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 6 times the upper normal limit
bilirubin equal or < 2 mg/dl
international normalized ratio (INR) < 1.7
serum creatinine equal or < 1.5 times the upper normal limit or creatinine clearance > or equal 60 ml/min
Albumin >2.8 mg/dl
not being pregnant - a negative pregnancy test is required (for women). Patients in fertile age should use a contraceptive method during treatment and 4 months after.

Exclusion Criteria

Patients with more than 5 discrete lesions in the liver
Main or common biliary duct invasion
Patients with main portal vein tumor thrombus or more than 2 portal branch thrombus
Patients in systemic treatment (sorafenib, chemotherapy). There should be an interval of at least 4 weeks between any medication for treatment of HCC and the current study treatment
Previous radiation to upper abdomen
Patients with other malignant neoplasms or previous malignant neoplasms will be accepted in the study if HCC prognosis is worse
Patients with ischemic myocardial infarction within the last 6 months
Patients with large esophageal varices with red color sign or bleeding within the last 3 months
Patients with symptoms of colitis, enteritis, esophagitis, fistula, ileus, necrosis, stenosis or ulcer
Patients with severe anorexy, constipation, dehydration, diarrhea or vomiting
Patients unable to understand and sign written informed consent

Study & Design

Arm && Interventions

Group	Intervention	Description
SBRT	SBRT	SBRT according to the intervention description

Primary Outcome Measures

Name	Time	Method
Local Progression Free Survival	5 years	Local Progression Free Survival will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) when clinically indicated. The exam will be performed every 3 months after the end of treatment. The tumor response will be measured according to the modified RECIST (mRECIST) directed to the HCC study. Local Progression Free Survival will be defined as increase of 20% in the sum of all diameters of the treated lesions. Time-to-event will be counted from the initiation of SBRT

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5 years	Time-to-event will be counted from the initiation of SBRT
Distant Progression Free Survival	5 years	Distant Progression Free Survival will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) when clinically indicated. The exam will be performed every 3 months after the end of treatment. The tumor response will be measured according to the modified RECIST (mRECIST) directed to the HCC study. Distant Progression Free Survival will be defined as the appearance of a new hepatic lesion, tumoral thrombus or distant metastases. Time-to-event will be counted from the initiation of SBRT
Toxicity	5 years	Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0). Toxicity will be evaluated weekly during treatment, monthly in the first 3 months after treatment and every 3 months after. Acute Toxicity will be defined as toxicity that develops within the first 3 months after initiation treatment. Chronic Toxicity will be defined as toxicity that develops after 3 months of initiation of treatment.

Recruitment & Eligibility