Table 1. Patient characteristics at baseline for the ITT population.
CED only (N = 19) | CED+GEF (N = 19) | All patients (N = 38) | |
---|---|---|---|
Sex | |||
Male; N (%) | 14 (73.7%) | 13 (68.4%) | 27 (71.1%) |
Female; N (%) | 5 (26.3%) | 6 (31.6%) | 11 (28.9%) |
Age at entry | |||
Under 65 at entry; N (%) | 15 (78.9%) | 15 (78.9%) | 30 (78.9%) |
65 or over at entry; N (%) | 4 (21.1%) | 4 (21.1%) | 8 (21.1%) |
Age at entry; median (range) | 61.0 (40–69) | 55.0 (30–71) | 57.0 (30–71) |
Resection for the recurrent disease | |||
No resection; N (%) | 15 (78.9%) | 17 (89.5%) | 32 (84.2%) |
Previous resection; N (%) | 4 (21.1%) | 2 (10.5%) | 6 (15.8%) |
Karnofsky Performance Status | |||
Median (range) | 90 (70–100) | 90 (80–100) | 90 (70–100) |
KPS < = 80; N (%) | 6 (31.6%) | 6 (31.6%) | 12 (31.6%) |
KPS > 80; N (%) | 13 (68.4%) | 13 (68.4%) | 26 (68.4%) |
Time from diagnosis to randomisation (months); median (range) | 10.2 (6.0–27.4) | 12.7 (6.7–29.4) | 12.1 (6.0–29.4) |