A Randomized Phase II Trial of Concurrent Gemcitabine and High-intensity Focused Ultrasound Therapy versus Gemcitabine Monotherapy for Locoregionally Advanced Pancreatic Cancer: A Preliminary Result

for the treatment of pancreatic cancer. Although we have made incremental progress in the treatment of pancreatic cancer, the prognosis of patients with this disease remains extremely poor. High-intensity Focused Ultrasound (HIFU) therapy is a new treatment for patients with advanced pancreatic cancer. Study Objective: To compare the effective of concurrent gemcitabine and HIFU therapy (GH) arm with the gemcitabine monotherapy (G) arm for locoregionally advanced pancreatic cancer. Patients and Methods: Of the 91 patients with locoregionally advanced requiring treatment, 85 fulfilled the inclusion criteria and were recruited for the trial, three refused to participate. The enrollment was closed when 82 patients were included, and 41 patients were allocated to each arm (GH or G). Results: No difference was observed between the GH arm and the G arm, in gender, performance status, stage, and location of primary tumor. There was significant difference in overall response between the two arms (22.0 % versus 12.2%, P<0.001). The 95 % confidential interval (CI) of the overall response was 9.3-34.7%, and 1.6-22.8 % of GH arm and G arm, respectively. The most striking change in the patients was that the preoperative pain disappeared immediately after high-intensity focused ultrasound treatment in the GH arm. And there was difference of the VAS score among the two arms (GH arm and G arm), with fou