NL-OMON44103
Recruiting
Phase 2
Transarterial Chemoembolization with Drug-Eluting Beads (standard arm) versus Stereotactic Body Radiation Therapy (experimental arm) for hepatocellular carcinoma: A multicenter randomized phase II trial *The TRENDY trial* - TRENDY trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 64
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Patients diagnosed with HCC (follow the diagnostic algorithm recommended by the EASL\*EORTC Clinical Practice Guidelines 2012\). The treatment can be delivered prior to liver transplantation.
- •\-Barcelona Clinic Liver Cancer Stage System class A\-B
- •\-One to three tumors with at most up to a cumulative diameter of \* 6 cm measured in all 3 axes. In case of multiple lesions, the most favorable setting would be that all are eligible for TACE\-DEB. If only one or two lesions are eligible for TACE\-DEB, and the others are eligible for ablation, the patient can still be included in the study. Satellite nodules count as independent lesions.
- •\-Earlier treatments with ablation are allowed until a maximum of 3 lesions, including the one, or ones, that will be randomized in the study. Lesions previously treated with ablation should not have exceeded a diameter of 3cm.
- •\-Measurable disease on CT/MRI\-scan, according to mRECIST criteria for HCC within 6 weeks prior to randomization
- •\-Tumor visibility on CT
- •\-None or cirrhosis Child\-Pugh A
- •\-Age \* 18 years
- •\-ECOG performance status 0\-1
- •\-Albumin\> 28 g/l, bilirubin \< 50 µmol/l, INR \< 2\.3, AST/ALT \< 5 times ULN, within 6
Exclusion Criteria
- •\-Eligibility for resection or RFA
- •\-More than three tumors in the liver
- •\-Any signs of acute viral or non\-viral hepatitis
- •\-Encephalopathy
- •\-Vascular tumor invasion (contact with the vessel will not be considered contraindication).
- •\-Previous radiotherapy to the liver
- •\-Known current pregnancy
- •\-Distance from the tumor to the esophagus, stomach, duodenum, small bowel or large bowel \< 0\.5 cm on CT or on MRI (randomization imaging).
- •\-Uncontrolled portal hypertension (high bleeding risk). If gastroscopy has been performed, untreated esophageal varices grade III or IV.
Outcomes
Primary Outcomes
Not specified
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