Status:
ACTIVE_NOT_RECRUITING
SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE
Lead Sponsor:
University of Sao Paulo
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This is a pilot study where patients with Hepatocellular Carcinoma (HCC) that have failed Transarterial Chemoembolization (TACE) will be treated with Stereotactic Body Radiation Therapy (SBRT). The fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02221778
Start Date
August 1 2014
End Date
December 1 2024
Last Update
December 6 2024
Active Locations (1)
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1
Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, Brazil, 01246000