Table 1.
Trial (year results published) | Study design | Patients | Follow-up (mo) | Treatment | Outcome: overall survival | Outcome: local recurrence |
Swedish Rectal Cancer Trial (1997)[10] | RCT | 1168 | 60 | Neoadjuvant short-course RT vs surgery alone | 58% vs 48% (P = 0.004) | 11% vs 27% (P < 0.001) |
Dutch TME Trial (2001)[11] | RCT | 1861 | 24 | Neoadjuvant short-course RT (standard TME ) vs surgery alone | 82% vs 81.8% (P = 0.84) | 2.4% vs 8.2% (P < 0.001) |
German Rectal Cancer Study Group (2004)[14] | RCT | 799 | 60 | Neoadjuvant long-course RT + chemotherapy vs adjuvant long-course RT + chemotherapy | 76% vs 74% (P = 0.80) | 6% vs 13% (P = 0.006) |
Polish Colorectal Group (2006)[16] | RCT | 312 | 48 | Neoadjuvant short-course RT vs neoadjuvant long-course RT | 67.2% vs 66.2% (P = 0.96) | 14.2% vs 9% (P = 0.17) |
MRC-NCIC (2009)[17] | RCT | 1350 | 60 | Neoadjuvant short-course RT vs selective adjuvant long-course RT + chemotherapy | 70% vs 67.9% (HR 0.91, 95% CI: 0.73 to -1.13, P = 0.40) | 4% vs 11% (HR 0.39, 95% CI: 0.27 to 0.58, P < 0.0001) |
NSABP R-03 (2009)[18] | RCT | 267 | 60 | Neoadjuvant long-course RT + chemotherapy vs postoperative long-course RT + chemotherapy | 74.5% vs 65.6% (P = 0.065) | 10.7% vs 10.7% (P = 0.69) |
Stockholm III (2010)1 | RCT | 303 | Ongoing | Neoadjuvant short-course RT + surgery within 1 wk vs neoadjuvant short-course RT + surgery 4 to 8 wk later vs neoadjuvant long-course RT + surgery 4 to 8 wk later | Ongoing |
Interim results. RCT: Randomized control trial; RT: Radiotherapy; TME: Total mesorectal excision; MRC-NICI: Medical Rectal Council-National Cancer Institute of Canada; NSABP: National Surgical Adjuvant Breast and Bowel Project; HR: Hazard ratio.