Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile .
There is no clear evidence to support one regimen over another .
PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer .
Phase III Trial of Radiosensitizer PR-350 Combined With Intraoperative Radiotherapy for the Treatment of Locally Advanced Pancreatic Cancer
Abstract : A r and omized , controlled trial was conducted to clarify the effect of novel radiosensitizer , PR-350 , accompanied by intraoperative radiology ( IOR ) on locally advanced pancreatic cancer . Between July 1999 and March 2002 , 48 patients were enrolled in this clinical trial and received either  PR-350 or placebo . Any differences between the PR-350 group ( n = 22 ) and control group ( n = 25 ) were not statically significant . All patients were evaluated , and none of them showed toxicity , with the exception of 1 patient from the control group , and the PR-350 compound was considered to be safe . The efficacy of IOR with PR-350 was evaluated using CT examination . The committee responsible for evaluating efficacy reported that 47.4 % of the PR-350 group showed the effective response , compared with 21.7 % of the control group ( P = 0.1067 , Fisher analysis ) . At 6 months following treatment , the tumor mass reduction rate in the PR-350 group was significantly improved ( P = 0.0274 ) . By the time of the last follow-up in July 2003 , 17 PR-350 patients and 24 control patients group had died of the disease . The median survival period of the PR-350 group was thus 318.5 days and that of the control group is 303.0 days . One-year survival rates of the PR-350 group and control group were 36.4 % and 32.0 % , respectively . Although the PR-350 group did not demonstrate significantly better survival than the control group , 4 of 22 PR-350 patients were still living more than 2 years after the end of the trial , compared with only 1 of 25 patients from the control group . The mechanism of this increased therapeutic response to radiotherapy using PR-350 must be clarified to establish more effective strategy for pancreatic cancer treatment
Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile .
There is no clear evidence to support one regimen over another .
PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer .