ABSTRACT
BACKGROUND: Therapeutic options for early-stage hepatocellular carcinoma (HCC) in individual patients can be limited by tumor and location, liver dysfunction and comorbidities. Many patients with early-stage HCC do not receive curative-intent therapies. Stereotactic ablative body radiotherapy (SABR) has emerged as an effective, non-invasive HCC treatment option, however, randomized evidence for SABR in the first line setting is lacking. METHODS: Trans-Tasman Radiation Oncology Group (TROG) 21.07 SOCRATES-HCC is a phase II, prospective, randomised trial comparing SABR to other current standard of care therapies for patients with a solitary HCC ≤ 8 cm, ineligible for surgical resection or transplantation. The study is divided into 2 cohorts. Cohort 1 will compromise 118 patients with tumors ≤ 3 cm eligible for thermal ablation randomly assigned (1:1 ratio) to thermal ablation or SABR. Cohort 2 will comprise 100 patients with tumors > 3 cm up to 8 cm in size, or tumors ≤ 3 cm ineligible for thermal ablation, randomly assigned (1:1 ratio) to SABR or best other standard of care therapy including transarterial therapies. The primary objective is to determine whether SABR results in superior freedom from local progression (FFLP) at 2 years compared to thermal ablation in cohort 1 and compared to best standard of care therapy in cohort 2. Secondary endpoints include progression free survival, overall survival, adverse events, patient reported outcomes and health economic analyses. DISCUSSION: The SOCRATES-HCC study will provide the first randomized, multicentre evaluation of the efficacy, safety and cost effectiveness of SABR versus other standard of care therapies in the first line treatment of unresectable, early-stage HCC. It is a broad, multicentre collaboration between hepatology, interventional radiology and radiation oncology groups around Australia, coordinated by TROG Cancer Research. TRIAL REGISTRATION: anzctr.org.au, ACTRN12621001444875, registered 21 October 2021.
Subject(s)
Carcinoma, Hepatocellular , Liver Neoplasms , Radiosurgery , Standard of Care , Humans , Liver Neoplasms/pathology , Liver Neoplasms/therapy , Liver Neoplasms/radiotherapy , Liver Neoplasms/surgery , Carcinoma, Hepatocellular/therapy , Carcinoma, Hepatocellular/pathology , Carcinoma, Hepatocellular/radiotherapy , Carcinoma, Hepatocellular/surgery , Radiosurgery/methods , Prospective Studies , Male , Female , Neoplasm Staging , Middle Aged , Randomized Controlled Trials as Topic , Aged , AdultABSTRACT
We present a 74-year-old male ex-smoker presenting with a 6-week history of personality change, confusion and headache. Magnetic resonance imaging revealed multiple supratentorial and infratentorial parenchymal masses, predominately in the frontal and parietal lobe white matter. A thin enhancing halo was demonstrated with central low signal intensity on T(1)-and T(2)-weighted imaging compatible with calcification. A tiny extra-axial lesion was also noted near the right cerebellopontine angle. Computed tomography (CT) scan confirmed the finding of a 'target' lesion with a central core of calcification and a ring of enhancement. The 'target sign' of intracerebral tuberculomata was first described in 1979 and reported to be pathognomic for this diagnosis in 1988. However, cerebral tuberculosis was considered unlikely clinically because the patient had recently completed a 12-month course of therapy for Mycobacterium avium complex respiratory infection with agents also active against Mycobacterium tuberculosis. He was afebrile and blood tests did not support an inflammatory process. Subsequent histopathology demonstrated metastatic papillary adenocarcinoma and immunohistochemical studies revealed the origin to be that of primary lung carcinoma. A spiculated pulmonary nodule was seen on CT scan but previous bronchoscopy failed to demonstrate malignant cells. In summary, the 'target sign' is a non-specific radiologic finding but most commonly indicates cerebral tuberculoma or metastatic adenocarcinoma in the appropriate clinical context.