Table 1.

TheraSphere in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (STOP-HCC) study schedule of assessments and events.

Interventions and Assessments		Sorafenib group: initiate treatment weeks 1-4; continue therapy weeks ≥5	TAREa+sorafenib group				Follow-up every 8 weeks ±14 daysc (for both groups)
			First workup and TARE treatment: Weeks 1-4	Second workup and TARE treatment for patients with bilobar disease: Weeks 5-8	Sorafenib treatment: initiate and continue sorafenib treatment >2 to <6 weeks after TARE	Workup and retreatmentb for patients with hepatic progression
Interventions
	Administer sorafenibd	✓			✓	✓c
	Calculate liver volume and mass		✓			✓
	Hepatic angiogram, 99mTc-MAA scanf, calculate TARE dose, administer TAREg		✓	✓		✓
Assessments
	ECOGh Performance Status		✓	✓		✓	✓i
	Hematologyj, coagulationk, chemistry panel, liver function tests	✓l	✓l			✓	✓m
	Tumor markers for hepatocellular carcinoma (alpha-fetoprotein)	✓	✓				✓m
	Triple-phase MRIn/spiral CTo abdomen, Child-Pugh score, spiral CT chest and pelvis, quality-of-life questionnaire						✓m
	Assess and report adverse events, review and record concurrent medication	✓	✓	✓		✓	✓m
	Final end point, efficacy and safety documentation, and exit patient						✓i

^aTARE: transarterial radioembolization.

^bAdditional TARE workup and administration in lesions amenable to further TARE.

^cThe follow-up visits should be scheduled from the day of randomization. A window of ±14 days is permissible from the scheduled date.

^dAccording to package insert at weeks 1-4 for sorafenib group patients and after all initial TARE administrations for TARE+sorafenib group patients only.

^eSorafenib to be stopped 7 days before subsequent TARE administration in disease progression and restarted 2 weeks after TARE is administered.

^f99mTc-MAA scan: technetium-99m macroaggregated albumin.

^gAdditional TARE may be administered only after progression if lesions are amenable to treatment.

^hECOG: Eastern Cooperative Oncology Group.

ⁱBoth before and after progression of disease resulting in termination of further treatment.

^jHematology tests: white blood cells, hemoglobin, hematocrit, and platelets.

^kCoagulation tests: prothrombin time, partial thromboplastin time, and international normalized ratio for prothrombin time.

^lIf treatment commences within 14 days of randomization, the clinical laboratory assessments are not required to be repeated.

^mPrior to progression of disease resulting in termination of further treatment.

ⁿMRI: magnetic resonance imaging.

^oCT: computed tomography.