Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial

Table 1 Timeline schedule for participants: screen, intervention, and follow-up

	Screening	Baseline/Enrollment Visit 0 (V0)	Treatment visit 1 (V1)	Follow up visit 2 (V2, week 6)	Follow up visit 3 (V3, week 12)	Follow up visit 4 (V4, week 24)	Follow up visit 5 (V5, week 36)	Follow up visit 6 (V6, week 48)	Follow up visit 7 (V7, week 60)	Follow up visit 8 (V8, week 72)	Follow up visit 9 (V9, week 84)	Follow up visit 10 (V10, week 96)
Informed consent form		✓
Randomization		✓
Demographics	✓
Medical history	✓
Physical examination^a	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Vital signs	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Performance status	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Concomitant medications	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Hemotology^b	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Serum biochemistry^c	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Hepatic disease examination^d	✓	✓
Abdominal CT or MRI	✓				✓		✓		✓		✓
Whole-body CT scan						✓		✓		✓		✓
EKG (as indicated)	✓
Fibrosis evaluation (Acoustic Radiation Force Impulse; ARFI)		✓
Pregnancy test (urine)^e		✓
Adverse event evaluation			✓	✓	✓	✓	✓	✓	✓	✓	✓	✓

^aInclusion of physical examinations for abdominal condition, ascites, encephalopathy, body temperature, weight, height, pulse, and blood pressure
^bInclusion of CBC/DC, PLT, WBC classification, ANC, and PT/APTT
^cInclusion of AST, ALT, Albumin, alkaline phosphatase, LDH, total protein, total bilirubin, direct bilirubin, BUN, Cr, sodium ([NA⁺]), potassium ([K⁺]), AFP, GGT, INR
^dInclusion of HBsAg and Anti-HCV. Note that the following items are selective: HBeAg, HBeAb, HBcAg, HBV DNA, and HCV-RNA
^eWomen with childbearing potential only
Note 1: It was desirable to follow the study calendar as outlined, despite progression disease (PD). For per monthly tests, +/− 1 week was permitted, and for per 3, 6 and 12 monthly tests, +/− 2 weeks were permitted
Note 2: This table was modified from recommendation of SPIRIT 2013 [46]
Abbreviation: CBC/DC complete blood count/differential count, PLT platelet, WBC white blood cell, ANC absolute neutrophil count, PT/APTT prothrombin time/activated partial thromboplastin time, AST Aspartate Aminotransferase, ALT alanine aminotransferase, LDH lactate dehydrogenase, BUN blood urea nitrogen, Cr Creatinine, AFP alpha-fetoprotein, GGT γ-Glutamyltransferase, INR international normalized ratio, HAV hepatitis A virus, HBsAg hepatitis B surface antigen, HCV hepatitis C virus, CT computed tomography, MRI magnetic resonance imaging

ISSN: 1471-2407