Demographic and clinical data
| Surgical arm | Clinical arm | Significance | |
| N | 130 | 125 | |
| ITT: 121 | ITT: 119 | ||
| Not eligible: 9 | Not eligible: 6 | ||
| Evaluable patients | 121 | 119 | |
| Age (years), mean | 47.2 | 49.6 | p=0.09 |
| Range | 20–69 | 24–71 | |
| BMI, mean | 26.2 | 26.2 | p=0.83 |
| Range | 16.4–48.1 | 15.7–51.4 | |
| Karnofsky index (%) | 90 (70–100) | 90 (70–100) | p=0.45 |
| Co-morbidity | |||
| Cardiovascular | 24 (19.8%) | 24 (20.2%) | p=0.95 |
| Diabetes | 9 (7.4%) | 7 (5.9%) | p=0.63 |
| Prior abdominal surgery | 56 (46.3%) | 46 (38.7%) | p=0.23 |
| Stage at randomization* | |||
| IIB | 85 (70.2%) | 80 (67.2%) | |
| IIIA | 4 (3.3%) | 6 (5%) | |
| IIIB | 29 (24%) | 24 (20.2%) | |
| IVA | 3 (2.5%) | 9 (7.6%) | p=0.44 |
| Tumor size* | |||
| ≤4 cm | 31 (25.6%) | 22 (18.5%) | |
| >4 cm | 90 (74.4%) | 97 (81.5%) | p=0.18 |
| Histology* | |||
| Squamous | 103 (85.1%) | 108 (90.8%) | |
| Adenocarcinoma | 15 (12.4%) | 8 (6.7%) | |
| Adenosquamous | 3 (2.5%) | 3 (2.5%) | p=0.33 |
| Grade* | |||
| G1 | 5 (4.1%) | 1 (0.8%) | |
| G2 | 85 (70.2%) | 76 (63.9%) | |
| G3 | 31 (25.6%) | 42 (35.3%) | p=0.046 |
| LVSI* | |||
| Negative | 98 (81%) | 101 (85%) | |
| Positive | 21 (17%) | 14 (12%) | |
| Indeterminate | 2 (2%) | 4 (3%) | p=0.24 |
| HVSI* | |||
| Negative | 109 (90%) | 111 (94%) | |
| Positive | 10 (8%) | 4 (3%) | |
| Indeterminate | 2 (2%) | 4 (3%) | p=0.11 |
*Only evaluable patients included in these sections.
HVSI, hemovascular space invasion: tumor cell invasion in microscopic blood vessels; LVSI, lymphovascular space invasion: tumor cell invasion in lymphatic vessels.