Table 1. Characteristics of patients entered in the phase I and II studies.
| Characteristics | Phase I, no. (%) | Phase II, no. (%) |
|---|---|---|
| Total patients | 20 (100) | 31 (100) |
| Males | 14 (70) | 16 (52) |
| Females | 6 (30) | 15 (48) |
| Median age (years) (range) | 63 (41–77) | 56 (29–74) |
| ECOG performance status | ||
| 0 | 9 (45) | 12 (39) |
| 1 | 11 (55) | 17 (55) |
| 2 | 0 | 2 (6) |
| Risk of failurea and TNM clinical staging | ||
| Low risk | ||
| T1–2/N0 | 1 (5) | 0 |
| Intermediate risk | ||
| T1–2/N1 | 0 | 1 (3) |
| T3N0 | 8 | 3 (10) |
| Moderately high risk | ||
| T1–2/N2 | 0 | 0 |
| T3N1 | 7 (35) | 14 (45) |
| T4N0 | 3 (15) | 0 |
| High risk | ||
| T3N2 | 0 | 7 (23) |
| T4N1–2 | 1 (5) | 6 (19) |
| Distance of primary tumour from anal verge | ||
| ⩽5 cm | 11 (55) | 15 (48) |
| 6–10 cm | 8 (40) | 12 (39) |
| >10 cm | 1 (5) | 4 (13) |
| Distance of tumour from mesorectal fascia b | ||
| ⩽5 cm | 3 (15) | 19 (61) |
| >5 cm | 3 (15) | 9 (29) |
| Not evaluated | 14 (70) | 3 (10) |
| CEA | ||
| =5 UI | 11 (55) | 21 (68) |
| >5 UI | 9 (45) | 10 (32) |
CEA=carcinoembryonic antigen assay; ECOG=Eastern Cooperative Oncology Group; TNM=tumour node metastasis.
a
Risk of failure evaluated according to Gunderson's classification.
b
Evaluated by MRI (only in patient treated with oxaliplatin). In two patients treated in the phase I and in three patients in the phase II studies, MRI was not performed because of metal prosthesis in four and metal stitches in the other.