Early Hepatocellular Carcinoma
Conditions
Keywords
SABR, Radiofrequency ablation, Transarterial chemoembolisation, Stereotactic Ablative Body Radiotherapy, RFA, TACE, TARE
Brief summary
This Phase II Prospective, parallel and open-label randomised control trial will investigate whether a radiotherapy technique (called SABR) can treat early stage liver cancer more effectively than current treatments which use heating probes directly inserted into the tumour or chemotherapy or radioactive particles injected into the blood supply of the tumour. Investigators hypothesize SABR will result in higher rates of freedom from local progression (FFLP) at 2 years compared to percutaneous thermal ablation ± TACE or transarterial therapies (TACE/TARE).The study will also look at other important outcomes such as progression free survival, overall survival, side effects, quality of life and people's experiences of their treatment.
Detailed description
The SOCRATES randomised controlled trial will assess the efficacy, toxicity, HRQoL profile and cost effectiveness of SABR compared to the current SOC treatment in patients with first diagnosis of unresectable, single nodule HCC. Participants will be placed into one of two groups based on the size of their tumour and whether thermal ablation is an appropriate treatment for them. The study will include about 218 participants in total. Participants will be randomly assigned to receive either SABR or the current standard of care. Standard care may include thermal ablation, transarterial chemoembolisation (TACE), or transarterial radioembolisation (TARE).
Interventions
SABR 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.
RADIATIONTherapies
Patients 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).
Sponsors
University Health Network, Toronto
Trans Tasman Radiation Oncology Group
Australasian Gastro-Intestinal Trials Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\) 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 active disease at the site. * 2\) 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. * 3\) Child-Pugh score =B7\* with no or diuretic-controlled ascites * 4\) ECOG performance status =2 * 5\) Platelets =50x109/L, Haemoglobin =80 g/L, Neutrophils =1.0x109/L, INR \<1.8 (except if on therapeutic anticoagulation) * 6\) 18 years of age or older and able to provide written consent
Exclusion criteria
* 1\) Presence of multifocal HCC, macrovascular invasion or extrahepatic disease * 2\) Prior treatment for any HCC within last 2 years. * 3\) Clinically evident ascites or hepatic encephalopathy * 4\) Prior abdominal radiation therapy that would preclude the delivery of protocol defined SABR to the tumour. * 5\) Untreated Hepatitis B or C * 6\) Known additional invasive malignancy (excluding non-melanoma skin cancer) that is progressing or required treatment within the last 2 years. * 7\) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from local progression (FFLP) | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 2 years | — |
| Overall survival (OS) | 2 years | — |
| Safety and adverse events (CTCAE v5.0) | 2 Years | — |
| Patient reported outcomes (EORTC QLQ-C30) | 2 Years | The C30 is a 30-item instrument that evaluates HRQOL comprised of five functional scales (physical, cognitive, emotional, social, and role) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, anorexia, constipation, diarrhea, and financial), and a global QoL scale. Responses are scored on a linear scale from 0 to 100. Higher scores on functioning/global health indicate a better, healthier state. Higher scores on symptom scales indicate a higher symptom burden or worse condition. |
| Patient reported outcomes (QLQ-HCC18) | 2 Years | QLQ-HCC18 is a questionnaire where patients report symptoms or problems on a scale of 1 (not much) to 4 (very much). Higher scores on symptom scales indicate a higher symptom burden or worse condition. |
| Cost-effectiveness analysis | 2 Years | Incremental cost per outcome |
Countries
Australia, Canada
Contacts
CONTACTMichael Yan, MD MPH FRCPC DABR
Outcome results
None listed