Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma
Trial Parameters
Brief Summary
The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled trial comparing primary surgery versus primary chemotherapy followed by surgery in patients with a resectable signet ring cell gastric adenocarcinoma
Eligibility Criteria
Inclusion Criteria: * adenocarcinoma of the stomach or the oesogastric junction of type III of Siewert classification,histologically proven with the presence of signet ring cells (according to WHO 2000 classification) or diffuse form (according to Lauren classification) on pre-therapeutic biopsies * tumoural stage IB, II or III (according to UICC-AJCC 2009) * patient judged resectable in a curative intent on inclusion * absence of distant metastasis * absence of peritoneal carcinomatosis during pre-treatment explorative laparoscopy * WHO performance status 2 or less * age over 18 or under 80 years * weight loss at the time of inclusion \< 15% * neutrophilic polynuclears more than 1500/mm3 * platelets more than 100000/mm3 * creatinine clearance more than 50 ml/min * serum-albumin more than 30 gram/l * bilirubin less than 1,5 normal * prothrombin rate over 80% * absence of prior treatment with chemotherapy or radiotherapy for gastric cancer * absence of kniwn child B or C cirrhosis * lef