Table 3.
Randomized trials of preoperative radiation therapy combined with chemotherapy in locally advanced rectal carcinoma
| Author, year published | n | Treatment arms | Local recurrence | Overall survival |
| Gérard et al[18], 2006 (FFCD-9203) | 742 | Arm 1 (367 patients): preoperative RT (45 Gy/25 fractions/5 wk) followed by TME between 3-10 wk after RT | At 5 yr follow-up | 5-yr survival rate |
| 16.5% Arm 1 | 67.9% Arm 1 | |||
| Arm 2 (375 patients): preoperative RT (45 Gy/25 fractions/5 wk) + CH (2 cycles: first on days 1-5 of RT and the second on days 29-33 of RT) followed by TME between 3-10 wk after CHRT | 8.1% Arm 2 | 67.4% Arm 2 | ||
| (P = 0.004) | (P = 0.684) | |||
| Bosset et al[19], 2006 (the EORTC Radiotherapy Group Trial 22921) | 1011 | Arm 1 (252 patients): preoperative RT (45 Gy/25 fractions/5 wk) followed by TME between 3-10 wk after RT | 5 yr of follow-up | 5-yr survival rate |
| 17.1% Arm 1 | 63.2% Arm 1 | |||
| Arm 2 (253 patients): Same RT as in Arm 1 + 2 cycles of CH (days 1-5 and 29-33 of RT) + TME between 3-10 wk after CHRT | 8.7% Arm 2 | 63.2% Arm 2 | ||
| 9.6% Arm 3 | 67.2% Arm 3 | |||
| Arm 3 (253 patients): Same RT as in Arm 1 + TME between 3-10 wk after RT + 4 cycles of CH postoperative | 7.6% Arm 4 | 67.2% Arm 4 | ||
| (P = 0.002) | (P = 0.12) | |||
| Arm 4 (253 patients) Same RT as in Arm 1 + 2 cycles of CH (days 1-5 and 29-33 of RT) + TME between 3-10 wk after CHRT + 2 cycles of CH postoperative | ||||
| Bujko et al[20], 2005 | 312 | Arm 1 (155 patients): preoperative RT (5 Gy × 5 d) followed by TME at 7 d after RT | 4 yr of follow-up | 4-yr survival rate |
| 59% Arm 1 | 67.2% Arm 1 | |||
| Arm 2 (157 patients): preoperative RT (45 Gy/25 fractions/5 wk) + 2 cycles of chemotherapy on weeks 1 and 5 of RT) followed by TME between 4-6 wk later. The cycle consisted of leucovorin 20 mg/m2 per day and, 10-20 min later, 5-fluorouracil 325 mg/m2 per day, both administered as rapid infusion on 5 consecutive days | 14.2% Arm 2 | 66.2% S alone | ||
| (P = 0.170) | (P = 0.960) |
TME: Total mesorectal excision; RT: Radiation therapy; CHRT: Chemo-radiation therapy; CH: Chemotherapy (Leukovorin 20 mg/m2 per day was delivered intravenously immediately before administration of Fluorouracil and Fluorouracil 350 mg/m2 per day was delivered during 20 min in 100 mL of saline infusion, 1 h before RT).