Status:
COMPLETED
Effectiveness and Safety of the Simultaneous Radiotherapy and Hyperthermia After Transarterial Chemoembolization in Hepatocellular Carcinoma Patients Combined With Portal Vein Tumor Thrombosis
Lead Sponsor:
Samsung Medical Center
Conditions:
Carcinoma. Hepatocellular
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The presence of portal vein tumor thrombosis (PVTT)in patients with HCC is one of the most significant prognostic factors for poor prognosis, without treatment, their survival is less than 3 months. I...
Detailed Description
1.1 Hepatocellular carcinoma (HCC) and standard treatment HCC is the third most common cause of cancer death globally. It is also the second cause of cancer mortality in Korea, despite the incidence o...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of HCC by at least one criterion listed below (korean liver cancer study group (KLCSG) guideline 2009) 1.1 Pathologically (histologically or cytologically) proven diagnosis of HCC 1.2 Liver nodule in high risk group 1.2.1 If alpha fetoprotein (AFP) ≥200 ng/mL , ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI 1.2.2 If AFP\<200 ng/mL, ≥2 typical HCC enhancing pattern on dynamic contrast enhanced CT, MRI, and angiography 1.3 ≥ 2 cm nodule in liver cirrhosis (LC), ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI
- Patients must have a diagnosis of PVTT 2.1 Early arterial enhancement and delayed washout on multiphasic CT or MRI
- Eastern cooperative oncology group performance status 0 1 2
- Age ≥ 20
- Unsuitable for resection or transplant or RFA
- Unsuitable for or refractory to TACE or drug eluting beads (DEB)
- Agreement of study-specific informed consent
- Assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry?
- Child-Pugh score A-B within 7 days prior to study entry
- Normal liver (Liver minus gross tumor volume) ≥ 700 cc
- Blood work requirements
- Absolute neutrophil count (ANC) ≥ 1,500 /mm3, Platelet ≥ 70,000/mm3, Hgb ≥ 8 g/dl
- Liver function test (LFT): Total bilirubin\<3.0 mg/dL, International normalized ratio(INR) \< 1.7, Albumin ≥ 2.8g/dL, Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT)\< 6 X normal
- Serum creatinine \< 1.5 X normal, or creatinine clearance ≥ 60 mL/min
- Male, consent contraception at least 6 months
- Childbearing potential woman, consent contraception at least 6 months
- Life expectancy more than 12 weeks
- Stable breathing more than 5 minutes
Exclusion
- Complete obstruction of main portal vein
- Pregnant and/or breastfeeding woman
- Previous upper abdominal RT history
- Uncontrolled active co-morbidity
- Another primary cancer history within 2 years
- Uncontrolled ascites or hepatic encephalopathy
- Connective tissue disease which known as radiation hypersensitivity
- Uncontrolled moderate to severe gastroduodenal ulcer or esophagogastric varices
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01911000
Start Date
September 1 2013
End Date
May 1 2016
Last Update
August 22 2016
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710