Table 1.
Prospective randomized comparisons between radiotherapy alone and chemoradiation.
| Study | Tx | N | RT dose (Gy) Total per fraction |
Chemo | pCR | SPS | LR at 5 years | OS at 5 years | DFS at 5 years | Incidence of distant metastases |
|---|---|---|---|---|---|---|---|---|---|---|
| EORTC (Boulis-Wassif et al.) [59] | CRT | 126 | 34.5/2.3 | 5-FU | 4.8% | 10.5% | 15.1% | 54% | — | 30% overall |
| RT | 121 | 34.5/2.3 | — | 2.5% | 5% | 14.9% | 41.3% | — | ||
| EORTC 22921 (Bosset et al.) [60–62] | CRT | 506 | 45/1.8 | FUFA | 13.7% | 52.8% | 8.7%* | 65.8% | 56.1% | 34.4% overall |
| RT | 505 | 45/1.8 | — | 5.3% | 50.5 | 17.1%* | 64.8% | 54.4% | ||
| FFCD 9203 (Gérard et al.) [63, 64] | CRT | 375 | 45/1.8 | FUFA | 11.4% | 52.7% | 8.1% | 67.4% | 59.4% | — |
| RT | 367 | 45/1.8 | — | 3.6% | 51.8% | 16.5% | 67.9% | 55.5% | — | |
| Polish trial (Bujko et al.) [65–67] | CRT | 157 | 50.4/1.8 | FUFA | 16% | 55.4% | 14.2% | 66.2%** | 55.6%** | 34.6% |
| RT | 155 | 25/5 | — | 1% | 56.1% | 9% | 67.2%** | 58.4%** | 31.4% | |
| GRECCAR I [68] | CRT | 101 | 45/1.8 | FUFA | 12.5% | 86% | 5% | — | — | — |
| RT | 106 | 45 + 18 | — | 7% | 83% | 6% | — | — | — | |
| Australian Intergroup [69] | CRT | 163 | 50.4/1.8 | FUFA | — | — | 4.4%# | 70% | 69% | — |
| RT | 163 | 25/5 | — | — | — | 7.5%# | 74% | 72% | — | |
| Lithuanian study [53] | CRT | 46 | 50/1.8−2 | FUFA | 13.1% | 69.6% | — | — | — | — |
| RT | 37 | 25/5 (delayed surgery) | — | 2.7% | 70.3% | — | — | — | — |
EORTC: European Organisation for the Research and Treatment of Cancer; FFCD: Fédération Francophone de la Cancérologie Digestive; RT: radiotherapy; pCR: pathological complete response; SPS: sphincter preserving surgery; LR: local recurrence; OS: overall survival; DFS: disease free survival; *in the groups not receiving postop chemotherapy (4 arm trial); **4-year data; #3-year data actuarial survival.