Multi-institutional Randomized Control Trial on the Efficacy of Adjuvant Chemotherapy Using Gemcitabine : A Preliminary Study

Background: We evaluated gemcitabine as postoperative adjuvant chemotherapy for patients with resectable advanced pancreatic cancer. Study design: Multi-institutional randomized control trial for phase IE clinical study. Patients and Methods: Patients who underwent a curative surgery for the pancreatic cancer of Stage n, fll, and F a were enrolled in this study. The chemotherapy group has been received administration of biweekly 1000mg/m2 gemcitabine for 6 months after surgery, while the surgery-alone group has not been received any anticancer drug. The primary end-point was the disease-free survival, over-all survival and feasibility. Results: Twelve patients were enrolled in this trial from 7 institutions from November 2001 to August 2003. The chemotherapy was well tolerated with mild symptomatic and hematologic toxi-cities. The Grade 3 toxicity was observed only in two patients; one was nausea and vomiting requiring dripped infusion and the other was leucocytopenia. However, from the close micro-scopic examination, only 6 patients were eligible. Conclusions: Adjuvant systemic chemotherapy using gemcitabine was feasible with acceptable adverse effects. Further investigation for gemcitabine - based chemotherapy is warranted