Context According to the current guidelines, adjuvant chemotherapy is an integral part of the treatment concept for advanced pancreatic cancer. Randomised controlled studies showed that postoperative chemotherapy prolongs survival and reduces the recurrence rate. Objective The aim of our project was to analyse the validity of the most important study on this topic (ESPAC-1) by evaluating the data published in four publications (study design 1993, trial progress report 1997, interim results 2001, final results 2004). Design Our detailed analysis of the validity of the ESPAC-1 trial included the study design, recruitment period, patient selection, randomisation, changes in the protocol, participating institutions, homogeneity of subjects, surgical quality, statistical methods and interpretation of results. Results We identified several shortcomings in the patient selection, participating clinics, randomisation, changes in the protocol, surgical quality, statistics and evaluation of the results. Conclusion Although all analyzed papers concerned the same trial, the detailed evaluation revealed many inconsistencies. We therefore conclude that the validity of the ESPAC-1 trial is not sufficient to make a recommendation for adjuvant chemotherapy for advanced pancreatic cancer.
Katrin Bauer, Christel Weiss, Doris Henne-Bruns
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