Patients diagnosed with HCC, Child-Pugh grade A, one tumor ≤
Conditions
Interventions
Patients with HCC will be randomized to receive the standard treatment, TACE-DEB loaded with doxorubicin or the experimental arm, SBRT.
Sponsors
Erasmus MC
Department of Radiotherapy
Eligibility
Inclusion 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 28 g/l, bilirubin 0.75x10E9/l, Hb > 6 mmol/l, within 6 weeks prior to randomization •Written informed consent •Willing and able to comply to the follow-up schedule •Planned to start treatment within 6 weeks from randomization.
Exclusion criteria
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 •Ascites •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study will be time to progression, defined as time from randomization to radiological progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be: -Time to local recurrence -Response rate (complete and partial response) -Overall survival -Toxicity -Quality of life | — |
Contacts
Public ContactA. Méndez Romero
Erasmus MC Cancer Institute, Department of Radiation Oncology
Outcome results
None listed