Table 1.
Baseline demographic and disease characteristics
| Variable | Arm A (n = 176) | Arm B (n = 179) | ||
|---|---|---|---|---|
| No. of patients | % | No. of patients | % | |
|
Age at randomization (mean, SD), years |
54.3 | 11.7 | 53.9 | 9.9 |
| Gender | ||||
| Male | 114 | 64.8 | 112 | 62.6 |
| Female | 62 | 35.2 | 67 | 37.4 |
| Race | ||||
| White | 159 | 90.9 | 161 | 91.5 |
| Black | 5 | 2.9 | 5 | 2.8 |
| Other | 11 | 6.3 | 10 | 5.7 |
| Ethnicity | ||||
| Hispanic | 8 | 4.6 | 20 | 11.2 |
| Non‐Hispanic | 160 | 90.9 | 146 | 81.6 |
| Unknown | 8 | 4.6 | 13 | 7.2 |
| ECOG PS | ||||
| 0 | 106 | 60.2 | 109 | 60.9 |
| 1 | 70 | 39.8 | 70 | 39.1 |
| Clinical bowel obstruction | ||||
| No | 154 | 87.5 | 165 | 92.2 |
| Yes | 22 | 12.5 | 14 | 7.8 |
| Bowel perforation | ||||
| No | 171 | 99.4 | 173 | 98.3 |
| Yes | 1 | 0.6 | 3 | 1.7 |
| Clinical T stage | ||||
| 1 | 1 | 0.6 | 0 | 0 |
| 2 | 7 | 4 | 13 | 7.4 |
| 3 | 161 | 91.5 | 159 | 89.8 |
| 4 | 7 | 4 | 5 | 2.8 |
| Clinical N stage | ||||
| 0 | 72 | 40.9 | 66 | 37.1 |
| 1 | 92 | 52.3 | 98 | 55.1 |
| 2 | 12 | 6.8 | 14 | 7.9 |
| Histologic grade | ||||
| Well (grade 1) | 20 | 12.5 | 31 | 18.8 |
| Moderate (grade 2) | 122 | 76.3 | 111 | 67.3 |
| Poor (grade 3) | 17 | 10.6 | 22 | 13.3 |
| Undifferentiated (grade 4) | 1 | 0.6 | 1 | 0.6 |
| Prior chemotherapy | ||||
| Prior oxaliplatin therapy | 45 | 26 | 43 | 25 |
| Prior capecitabine therapy | 71 | 41.5 | 44 | 26 |
| Prior continuous 5‐FU infusion | 95 | 54.9 | 119 | 69.6 |
| Prior 5‐FU and leucovorin | 8 | 4.7 | 7 | 4.2 |
|
Prior RT total dose, mean, SD |
50.5 | 2.8 | 50.4 | 2.7 |
| Prior RT total dose, median, range | 50.4 | 43.2–55.8 | 50.4 |
41.4– 55.8 |
| Primary surgery type | ||||
| Low anterior resection | 63 | 35.8 | 71 | 39.7 |
| Abdominal perineal resection | 59 | 33.5 | 60 | 33.5 |
| Low anterior resection/coloanal anastomosis | 43 | 24.4 | 38 | 21.2 |
| Other | 11 | 6.3 | 10 | 5.6 |
| Complete resection | ||||
| No | 6 | 3.4 | 4 | 2.2 |
| Yes | 170 | 96.6 | 175 | 97.8 |
| Ostomy created | ||||
| No | 35 | 20.2 | 29 | 16.9 |
| Yes, colostomy | 71 | 41 | 73 | 42.4 |
| Yes, ileostomy | 67 | 38.7 | 70 | 40.7 |
| Sphincter preserved | ||||
| No | 62 | 35.4 | 65 | 36.7 |
| Yes | 113 | 64.6 | 112 | 63.3 |
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; RT, radiation therapy.