Table 4.
Summary of randomized controlled trials concerning chemoradiation in patients with locally advanced pancreatic carcinomas.
| Trial | Year | Country/Region | N | Regimens | Outcomes |
|---|---|---|---|---|---|
| Chauffert [77] (2000-01 FFCD/SFRO) | 2008 | France | 119 | CRT (60 Gy, 5-FU/cisplatin) plus maintenance gemcitabine chemotherapy (n = 59) vs. gemcitabine chemotherapy (n = 60) | mOS 8.6 mo vs. 13 mo (p = 0.03); 1-year OS 32% vs. 53%; 1-year PFS 14% vs. 32% |
| Loehrer [78] | 2011 | USA | 74 | CRT (50.4 Gy, gemcitabine) (n = 34) vs. gemcitabine chemotherapy (n = 37) | mOS 11.1 mo vs. 9.2 mo (p = 0.017); mPFS 6.0 mo vs. 6.7 mo; response 6% vs. 5%; stable 68% vs. 35% |
| Hammel (LAP-07) [79] | 2016 | International | 449 | gemcitabine (n = 223) vs. gemcitabine + erlotinib (n = 219) | From first randomization, mOS 13.6 mo vs. 11.9 mo (p = 0.09); mPFS 7.8 mo vs. 6.5 mo (p = 0.26) |
| 269 | chemotherapy same as previously for 2 mo (n = 136) vs. CRT (54 Gy, capecitabine) (n = 133) | From first randomization, mOS 16.5 mo vs. 15.2 mo (p = 0.83); mPFS 8.4 mo vs. 9.9 mo (p = 0.06); local progression 46% vs. 32% (p = 0.03) | |||
| Li [80] | 2003 | Taiwan | 34 | CRT (50.4~61.2 Gy, gemcitabine) (n = 18) vs. CRT (50.4~61.2 Gy, 5-FU) (n = 16), both followed by gemcitabine chemotherapy | mOS 14.5 mo vs. 6.7 mo (p = 0.027); 1-y OS 56% vs. 31%; 2-y OS 15% vs. 0%; mTTP 7.1 mo vs. 2.7 mo (p = 0.019); response 50% vs. 12.5% (p = 0.005) |
| Wilkowski [81] | 2009 | Germany | 95 | CRT (50 Gy, 5-FU) (n = 30) vs. CRT (50 Gy, gemcitabine/cisplatin) (n = 32) vs. CRT (50 Gy, gemcitabine/cisplatin) followed by gemcitabine/cisplatin chemotherapy (n = 31) | mOS 9.6 mo vs. 9.3 mo vs. 7.3 mo (p = 0.61); 9-mo OS 58% vs. 52% vs. 45%; mPFS 4.0 mo vs. 5.6 mo vs. 6.0 mo (p = 0.21); response 19% vs. 22% vs. 13% |
| Mukherjee and Hurt [82,83] | 2013 and 2017 | UK | 114 | Induction chemotherapy with gemcitabine and capecitabine for 12 weeks, if no tumor progression, then chemotherapy with gemcitabine and capecitabine for another cycle; then CRT (50.4 Gy, capecitabine) (n = 36) vs. CRT (50.4 Gy, gemcitabine) (n = 38) | mOS 17.6 mo vs. 14.6 mo (p = 0.185); 1-year OS 79.2% vs. 64.2%; mPFS 12.0 mo vs. 10.4 mo (p = 0.120); 9-mo PFS 62.9% vs. 51.4%; response (26 weeks) 23% vs. 19% |