[The German EORTC Study of neoadjuvant therapy of stomach carcinoma]

The improvement of the prognosis of gastric cancer after neoadjuvant therapy was shown in a phase II study with etoposide, adriamycin and cisplatinum (EAP). Due to high-grade toxicity with EAP, the verification of this therapeutic concept in a randomized phase III study with a less toxic regimen had to be demonstrated in a second phase II study. A combination with cisplatinum, leucovorin and 5-FU in comparison to EAP was less toxic, but clinical response after chemotherapy was shown to be identical. Of 41 patients, 36 patients underwent surgery with a R0-resection rate of 73.2% (n = 26). After a median follow-up of 18.3 months, 23 patients with R0 resection were alive, 19 patients (73%) showed no evidence of recurrent disease. There was no major morbidity and no postoperative mortality observed. Thus, chemotherapy with cisplatinum, 5-FU and leucovorin seems to be suitable for a randomized multicenter trial sponsored by the EORTC. For entrance into the study the following requirements should be met: prospective diagnostic procedures including endoscopic ultrasound (EUS) and surgical laparoscopy; standardised surgery (gastrectomy with D2-lymphadenectomy): prospective histopathological work up of the resected specimen including ypTNM category, ypUICC stages and R classification; prospectively scheduled follow-up intervals. Aim of the study, including 198 patients per treatment arm with a recruitment of 3 years and a minimum follow-up of 2 years, is the verification of the positive prognostic impact of neoadjuvant chemotherapy followed by surgery compared with surgery alone in locally advanced gastric cancer (cuT 3cN1-3cM0).