TRENDY trial

Recruiting

• Conditions: Patients diagnosed with HCC, Child-Pugh grade A, one tumor ≤ 6cm, and ≥ 18 years old.

• Registration Number: NL-OMON28819
• Lead Sponsor: Erasmus MCDepartment of Radiotherapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

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
•Albumin> 28 g/l, bilirubin < 50 µmol/l, INR < 2.3, AST/ALT < 5 times ULN, within 6 weeks prior to randomization
•Platelets ≥ 50x10E9/ l, neutrophils > 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study will be time to progression, defined as time from randomization to radiological progression

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints will be:<br>-Time to local recurrence <br>-Response rate (complete and partial response) <br>-Overall survival <br>-Toxicity <br>-Quality of life