NL-OMON28819
Recruiting
Not Applicable
Transarterial Chemoembolization with Drug-Eluting Beads (standard arm) versus Stereotactic Body Radiation Therapy (experimental arm) for hepatocellular carcinoma: A multicenter randomized phase II trialThe TRENDY trial”
Erasmus MCDepartment of Radiotherapy0 sites100 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients diagnosed with HCC, Child-Pugh grade A, one tumor ≤
- Sponsor
- Erasmus MCDepartment of Radiotherapy
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must be discussed in a multidisciplinary liver tumor board and should meet all of the following criteria:
- •Patients diagnosed with HCC (follow the diagnostic algorithm recommended by the
- •EASL–EORTC Clinical Practice Guidelines 2012\) \[1].
- •Barcelona Clinic Liver Cancer Stage System class A\-B
- •One tumor of maximum diameter ≤ 6 cm measured in all 3 axes. A maximum of two satellite nodules around the main tumor are accepted. Satellite nodules should fulfill the following criteria: Distance from the main tumor to the inner border of the nodules should be \< 1 cm, maximum diameter of each nodule should be ≤ 5 mm, maximum diameter of the main tumor together with the nodules should be ≤ 6 cm in all 3 axes.
- •Measurable disease on CT/MRI\-scan, according to mRECIST criteria for HCC within 6 weeks prior to randomization \[44].
- •Tumor visibility on CT
- •Child\-Pugh A cirrhosis
- •Age ≥ 18 years
- •ECOG performance status 0\-1
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Eligibility for resection or RFA
- •More than one tumor 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 \< 2 cm on CT or on MRI. 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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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*NL-OMON44103Erasmus MC, Universitair Medisch Centrum Rotterdam64
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