In a muti-institutional prospective trial conducted from 2003-2005, 74 patients with unresectable pancreatic adenocarcinoma were randomly assigned to receive GEM alone (at 1,000 mg/m /wk for weeks 1-6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m /wk for weeks 1-5, then 4 weeks later 1,000 mg/m /wk for 3 of 4 weeks) plus radiotherapy for a total of 50.4 Gy. Measurement of quality of life also was performed. Patients enrolled in Arm B (GEM plus radiation) had a higher incidence of grades 4 and 5 toxicities (41% vs 9%), but grades 3 and 4 toxicities combined were similar in both arms. No statistical difference was noted in quality of life. The primary endpoint of survival was improved with the addition of radiotherapy with 11.1 months for Arm B and 9.2 months for Arm A.
