sbrt or tace for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: randomized study of stereotactic body radiation therapy (sbrt) versus transarterial chemoembolization (tace) in locally advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * hcc (biopsy or radiological diagnostic (\>1 cm, enhancing in arterial phase and wash-out in later phases). * number of lesions: not more than 3 lesions * lesion size: up to 10 cm for a single lesion (and up to 10 cm cumulative diameter, if there is more than 1 lesion) * child-pugh a or b (\<7) on examination within 6 weeks prior to study entry * bclc stage a/b * must be fit (eligible) for sbrt and tace * unsuitable/unwilling for resection or transplant or radiofrequency ablation (rfa) or if these options are not available * distance between gtv (lesion) and luminal structures (including esophagus, stomach, duodenum, small or large bowel) is \>10 mm * all blood work obtained within 2 weeks prior to study entry with adequate organ function defined as follows: * absolute neutrophil count (anc) ≥ 1,500 cells/mm3 * platelets ≥50,000 cells/mm3 * hemoglobin ≥ 8.0 g/dl (note: the use of transfusion or other intervention to achieve hgb ≥ 8.0 g/dl is acceptable.) * total bilirubin \< 2 mg/dl * prothrombin time/inr \< 1.4 (unless on coumadin/warfarin) * albumin ≥ 28 g/l * ast (and alt) \< 5 times uln * serum creatinine ≤ uln or creatinine clearance ≥ 60 ml/min * left-ventricular ejection fraction \>50% (cardiac ejection fraction should be measured in case of history of cardio-vascular disease. * may have had previous surgery, ethanol injection and rfa to the liver exclusion criteria: * • not suitable for clinical trial or follow-up * prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible). no active cancer therapy. * unsuitable for or refractory to transarterial hepatic chemo-embolization (tace) * non-enhancing hcc on ct or ct-angio or * portal vein thrombosis/macroscopic venous invasion * arterio-portal and arterio-venous fistulas observed on pre-study imaging (if it is found during the tace, the fistula may be embolized before injection of the drug). * evidence of metastatic disease including nodal or distant metastases. * previous tace or radiation to the liver (including sirt) * life-threatening condition (including untreated hiv and active hepatitis b/c) * detectable hbeag and hbv viral load \> 20,000 iu/ml or * hbeag-negative chronic hepatitis b and hbv viral load \>2,000 iu/ml * if hbv-dna copy is higher than 500 copies/ml, anti-viral therapy, such as entecavir followed by observation for 2 weeks. * if anti-hcv antibody is positive (may be false positive) and increased hcv viral load indicating active disease. active hcv should be treated sufficiently before inclusion in the study. below 2 million copies per milliliter (ml) is related to chronic hepatitis c that does not need antiviral therapy. * patients with active hepatitis b or c should be on treatment for at least 4 weeks before inclusion in the trial * on sorafenib or other antineoplastic drug therapy within 7 days before inclusion (not accepted until time of progression). * pregnancy or women of childbearing potential require a negative pregnancy test within 28 days

Keywords: stereotactic body radiation therapy transarterial chemoembolization sbrt tace