A randomised, prospective, multicenter, phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resected pancreatic cancer

LBA4013 Background: Chemotherapy with Gemcitabine 1 g/m2 given on d 1, 8, 15 every four weeks is standard therapy in inoperable pancreatic cancer. The value of adjuvant therapy has not been clearly defined and no data on randomised trials with Gemcitabine in the adjuvant setting is available. Methods: This study was designed to evaluate the efficacy and toxicity of Gemcitabine in patients with resectable pancreatic cancer. Within 6 weeks after operation, patients were randomised to receive Gemcitabine or observation after stratification for positive or negative resection margins, nodal tumor involvement and tumor stage. Gemcitabine was administered at a dosage of 1g/m2 days 1, 8 and 15 every 4 weeks for 6 months. Patients in the observation arm received no specific postoperative treatment. Primary endpoint was disease free survival (DFS), secondary endpoints included overall survival (OS) and side effects in both groups. The study was powered to detect a significant difference with 90% probability at a si...