Patients' demographics and clinical characteristics.
| Arm A (LV5FU2-CDDP in first line) | Arm B (gemcitabine in first line) | |||
| n | % | n | % | |
| Patients | 102 | 100 | ||
| Female sex | 37 | 36 | 35 | 36 |
| WHO PS | ||||
| 0 | 28 | 27 | 30 | 30 |
| 1 | 51 | 50 | 53 | 53 |
| 2 | 22 | 21 | 14 | 14 |
| Not determined | 1 | 1 | 3 | 3 |
| Primary tumour location | ||||
| Head | 57 | 56 | 49 | 49 |
| Other | 44 | 43 | 50 | 50 |
| Unknown | 1 | 1 | 1 | 1 |
| Site of metastases | ||||
| Liver | 87 | 85 | 90 | 90 |
| Lung | 15 | 15 | 12 | 12 |
| Lymph nodes | 18 | 18 | 24 | 24 |
| Peritoneum | 11 | 11 | 17 | 17 |
| Other | 7 | 7 | 8 | 8 |
| Prior treatment | ||||
| Chemotherapy | 0 | 0 | 3 | 3 |
| Radiotherapy | 1* | 1 | 2* | 2 |
| Surgery | 23 | 23 | 27 | 27 |
| Resection | 13 | 57 | 14 | 40 |
| Drainage | 4 | 17 | 8 | 30 |
| Others | 6 | 26 | 6 | 22 |
| Radiological/endoscopic drainage | 22 | 22 | 11 | 11 |
| Duodenal stenting | 10 | 10 | 5 | 5 |
| Age (years) | Median (min–max) 62 (40–84) | Median (min–max) 65 (39–81) | ||
| Biological tumorous marker | ||||
| CEA (ng/ml) | 9 (0–2224) | 7(1–3604) | ||
| CA 19-9 (UI/ml) | 565(0–862200) | 560(1–156649) | ||
↵* Radiotherapy >4 weeks before randomisation.
CA 19-9, cancer antigen 19-9; CEA, carcinoembryonic antigen; LV5FU2-CDDP, 5-fluorouracil, folinic acid and cisplatin combination; PS, performance status.