Status:
COMPLETED
Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
Lead Sponsor:
Johannes Gutenberg University Mainz
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.
Eligibility Criteria
Inclusion
- ≥18 years
- HCC, proven by histology or according to EASL criteria
- Intermediate stage HCC (stage B according to BCLC)
- At least one measurable lesion in magnetic resonance imaging (MRI)
- Tumor load ≤ 50%
- preserved liver function (Child Pugh A and B)
Exclusion
- Patients feasible for curative treatment (e.g. resection or local ablation)
- Previous TACE or SIRT
- Chemotherapy during the last 4 weeks
- Child Pugh stage C
- BCLC stage D
- ECOG Performance Status \>0
- Tumor involvement \>50% of the liver
- Extrahepatic tumor
- Serum Bilirubin \>2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine \>2 mg/dl; Leukocytes \<3000/ml; Thrombocytes \<50000/ml
- Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
- Esophageal bleeding during the last 3 months
- Hepatic encephalopathy
- Transjugular intrahepatic portosystemic shunt (TIPS)
- Infiltration or occlusion of the portal vein
- Hepatofugal blood flow in the portal vein
- Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan
- Contraindications against angiography
- Gravidity
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01798160
Start Date
February 1 2010
End Date
May 1 2013
Last Update
October 20 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.