Table 1.
Baseline demographic and clinical characteristics in the intention-to-treat population
| Variable | Group A (Neoadjuvant chemotherapy) (n = 146) | Group B (Standard-of-care) (n = 138) | P Value | |
|---|---|---|---|---|
| Age at randomisation (years) | Mean ± SD | 58.29 ± 8.496 | 59.72 ± 9.137 | NA |
| Range | 41–74 | 30–72 | NA | |
| Sex | Female | 65 (44.52%) | 43 (31.16%) | NS |
| Male | 81 (55.48%) | 95 (68.84%) | NS | |
| EUS / MRI | T3N0 | 84 (57.53%) | 56 (40.58%) | NS |
| T3N1 | 37 (25.34%) | 40 (28.99%) | NS | |
| T3N2 | 4 (2.74%) | 17 (12.32%) | < 0.05 | |
| T4N0 | 4 (2.74%) | 13 (9.42%) | < 0.05 | |
| T4N1 | 5 (3.42%) | 12 (8.70%) | NS | |
| T4N2 | 12 (8.22%) | 0 (0.00%) | < 0.05 | |
|
Distance to anal verge (cm) EUS / MRI |
≤ 5 | 73 (50.00%) | 58 (42.03%) | NS |
| 5.1–10 | 42 (28.77%) | 57 (41.30%) | NS | |
| 10.1–15 | 31 (21.23%) | 23 (16.67%) | NS | |