A multi-institutional comparative trial of radiation therapy alone and in combination with 5-fluorouracil for locally unresectable pancreatic carcinoma. The Gastrointestinal Tumor Study Group.

One hundred six patients with histologically confirmed pancreatic carcinoma were randomized to one of three radiation treatment programs: 1) radiation therapy alone to 6000 rads; 2) 6000 rads plus 6-FU; or, 3) 4000 rads plus 5-FU. Patient survival was the primary study parameter. Both 4000 rads plus 5-FU (p less than .02) and 6000 rads plus 5-FU (p less than .01) were associated with a significantly longer patient survival than 6000 rads alone. Respective median survivals were 36 weeks, 40 weeks, and 20 weeks. The survival difference between 4000 rads plus 5-FU and 6000 rads plus 5-FU was not statistically significant at the time point selected.

RCT Entities:   Population Interventions Outcomes