gms | German Medical Science

Carcinoma of the exocrine pancreas has an especially poor prognosis. The five-year survival for all stages is <1% with a median survival of 4-6 months. Even after surgical intervention with a curative intention the two-year survival is only 25%. We initiated in August 2004 a phase III trial where we compare chemoradioimmunotherapy (CapRI) with 5-FU plus folinic acid, i.e. the best arm of the first large European randomised ESPAC-1 trial. The chemoradioimmunotherapy protocol is based on results from a phase I/II trial from the Virginia Mason Clinic. They have recently published data of postoperative cisplatin, 5-fluorouracil, interferon alpha-2b, and external-beam radiation administered following pancreatico-duodenectomy. They have treated 43 patients with mainly stage III tumors. 84% had positive lymph nodes and 19% had positive cut margins. After a mean follow-up of 31.9 months, 67% of the patients were still alive. Actuarial overall survival for the 1-, 2-, and 5-year survival rate were 95%, 64%, and 55%, respectively. Primary objective is the overall survival in both arms. Secondary objective is to evaluate the role and the mechanism of interferon alpha 2b in patients chemoradiation regimen, to assess the toxicity, the disease-free interval, the quality of life and to test different factors for their potential role as predictive marker. A total of 110 patients with R0 or R1 resected pancreatic adenocarcinoma will be enrolled. Recruiting phase should be finished after 1 ½ years. With a follow-up of two years a total running-time of approx. 3 ½ years should be expected. Currently,52 patients are enrolled. The treatment scheme isless toxic than expected,patients could be treated as outpatients. The main CTC grade III toxicities are leukopenia, hand-foot-syndrome, stomatitis, Fatigue-syndrome and hypo-calcemia. To conclude, the treatment scheme is feasible but an experienced interdisciplinary group is needed. First clinical results are expected for end of 2006.