Table 2.
Study designs
| Author | Study type | Intervention | Comparator | Location(s) |
|---|---|---|---|---|
| Seidensticker 2012 | Non-randomized observational study [matched analysis based on prior treatment history, tumor burden, liver involvement., synchronous versus metachronous metastases, alkaline phosphatase (ALP) increase, and carcinoembryonic antigen (CEA)] | SIRT (n = 29) | BSC (n = 29) | Germany |
| Hendlisz 2010 (NCT00199173) | Randomized open-label trial | SIRT + 5-fluorouracil (n = 21) | 5-fluorouracil with cross-over to SIRT upon progression at investigators' discretion (n = 23) | Belgium |
| Bester 2012 | Non-randomized interventional study of SIRT with control group formed of patients ineligible for SIRT patients (multivariable regression including potential prognostic factors conducted for survival analysis only). CRC patients only | SIRT (n = 224) | BSC (n = 29) | Australia |
| Yoshino 2012 (JapicCTI-090880) | Randomized double-blind trial | TAS-102 at 35 mg/m2 twice daily (n = 112) | Placebo + BSC (n = 57). Cross-over not permitted | Japan |
| Mayer 2015 (RECOURSE, NCT01607957) | Randomized double-blind trial | TAS-102 at 35 mg/m2 twice daily (n = 534) | Placebo + BSC (n = 266). Cross-over not permitted | Japan, United States, Europe, and Australia |
| Li 2015 (CONCUR, NCT01584830) | Randomized double-blind trial | Regorafenib at 160 mg/day (n = 136) | Placebo + BSC (n = 68) | China, Hong Kong, South Korea, Taiwan, and Vietnam |
| Grothey 2013 (CORRECT, NCT01103323) | Randomized double-blind trial | Regorafenib at 160 mg/day (n = 505) | Placebo + BSC (n = 255). Crossover not permitted | North America, western Europe, Israel, Australia, Asia, and Eastern Europe |
BSC best supportive care, CRC colorectal cancer, SIRT selective internal radiation therapy