RecruitingPhase 2ACTRN12621001444875

A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HCC (The SOCRATES HCC Study)

Sponsor

Trans Tasman Radiation Oncology Group (T/A TROG Cancer Research)

Enrollment

218 participants

Start Date

Nov 29, 2022

Study Type

Interventional

Conditions

Early Hepatocellular Carcinoma

Summary

The SOCRATES HCC study aims to investigate whether a radiotherapy technique (called Stereotactic Ablative Body Radiotherapy or SABR) can improve outcomes for people with early stage liver cancer compared to other current treatments. Currently, what treatment patients with early stage liver cancer are offered vary in individual circumstances but include; • Radiofrequency ablation (RFA) or microwave ablation (MWA) that use heating probes directly inserted into the tumour to kill the cancer cells. • Transarterial chemoembolisation (TACE) or transarterial radioembolisation (TARE) that uses chemotherapy or radioactive particles injected into the blood supply of the tumour to kill the cancer cells. • SABR is a highly precise radiation therapy technique that uses high energy x-rays focused on the tumour to kill the cancer cells. Who is it for? People who are 18 years of age or over AND have been diagnosed with primary hepatocellular carcinoma (single lesion with the largest diameter equal to or less than 5 cm), AND have not received any prior treatment for this. Study details: Participants in this study are randomly allocated (by chance) to one of two groups. - Patients in Group 1 will receive radiation therapy using a technique called Stereotactic Ablative Body Radiotherapy (SABR) that will be delivered in 3 or 5 outpatient treatment sessions (each 20 to 45 minutes in duration) spaced out over 1 to 2 weeks. The exact number of treatment sessions received, and the duration of each session depends on the size and location of the liver cancer. - Patients in Group 2 will receive standard of care treatment (SOC) as per their institution's local practice that will be administered by a doctor called an Interventional Radiologist. The therapies offered will depend on the size and location of the liver cancer and may include one or a combination of radiofrequency ablation (RFA) / microwave ablation (MWA) and/or transarterial chemoembolization (TACE) / transarterial radioembolisation (TARE). This may require an anaesthetic and an overnight admission to the hospital. Regular follow-up visits will be scheduled at 4 weeks post-treatment and then 3 monthly intervals for 2 years and then 6 monthly until completion of the trial. The same procedures will be repeated but also include imaging; CT or MRI of the liver, blood tests, clinical assessments and a questionnaire on the patient's health status (collected 6 monthly until completion of the trial).

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria10

Histological or radiological diagnosis of single, new HCC with largest diameter =8 cm (BCLC stage 0 or A).
a) If prior history of HCC, the prior HCC must have been:
Early stage, solitary HCC, =5 cm in size and,
Have arisen within a different liver segment to the current HCC and,
Treated with curative intent therapy >2 years prior with no evidence of activedisease at the site.
As per local multidisciplinary HCC meeting consensus patient is suitable for percutaneous thermal ablation and/or transarterial therapies and not suitable for or declined liver resection and not planned for liver transplantation.
Child-Pugh score =B7* with no or diuretic-controlled ascites
ECOG performance status =2
Platelets =50x109/L, Haemoglobin =80 g/L, Neutrophils =1.0x109/L, INR <1.8 (except if on therapeutic anticoagulation)
18 years of age or older and able to provide written consent

Exclusion Criteria7

Presence of multifocal HCC, macrovascular invasion or extrahepatic disease
Prior treatment for any HCC within last 2 years.
Clinically evident ascites or hepatic encephalopathy
Prior abdominal radiation therapy that would preclude the delivery of protocol defined SABR to the tumour.
Untreated Hepatitis B or C
Known additional invasive malignancy (excluding non-melanoma skin cancer) that is progressing or required treatment within the last 2 years.
Pregnancy

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Interventions

Each participant will be allocated into a cohort based on the following criteria; - Patients with HCC equal to or less than 3 cm deemed eligible for percutaneous thermal ablation will be allocated t

Each participant will be allocated into a cohort based on the following criteria; - Patients with HCC equal to or less than 3 cm deemed eligible for percutaneous thermal ablation will be allocated to Cohort 1 - Patients with HCC greater than 3cm or (HCC equal to or less than 3 cm) deemed ineligible for percutaneous thermal ablation will be allocated to Cohort 2 Interventions: Cohort 1: Participants will be randomised (1:1) to receive either percutaneous ablation (PA) (either radiofrequency ablation (RFA) or microwave ablation (MWA) technique) versus Stereotactic Ablative Body Radiotherapy (SABR). Cohort 2: Participants will be randomised (1:1) to receive SOC therapies versus SABR. - SOC therapies may include transarterial therapies (such as transarterial chemoembolization (TACE) or transarterial radioembolisation (TARE)) and/or MWA/RFA (alone or in combination) PA and transarterial therapies will be performed as per local hospital protocols. SBRT technique will follow a standardised protocol with allowable dose ranges stipulated below. Centres will be required to have completed the Trans Tasman Radiation Oncology Group (TROG) SBRT credentialing process prior to being activated. Interventions are to be delivered within 42 days of randomisation as follows: 1) SBRT: 36-45Gy in 3 fractions (ie 3 treatment sessions) or 40-50Gy in 5 fractions (ie 5 treatment sessions) delivered on 2-3 non-consecutive days/week. - Each treatment session will take around 30-60 mins as a day procedure. 2) PA (RFA or MWA): To be given as per local practice. - Ultrasound or CT guided aiming for ablation margin of >5mm, the prescribed voltage will follow the local prescribed algorithm depending on the lesion size (generally administer 100kW to one lesion for 2-4 mins). Verification with post-ablation contrast enhanced CT. - Eligible candidate will receive one treatment session, which usually takes around 45-60 mins. 3) Transarterial therapies (TACE or TARE): To be given as per local practice. - Eligible candidate will receive one treatment session, which usually takes around 60-90 mins.