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Introduction: Variability in the definition of survival endpoints in oncology trials was identified. Lack of a formal consensus could cause this, which limits inter-trial comparisons. The DATECAN project aimed at obtaining a formal consensus recommendation for defining survival endpoints for randomized clinical trials (RCTs) in the following cancer sites: pancreas, sarcoma/GISTs, breast, colorectal, gastric/oesophagus, head and neck, kidney-bladder. We report results for pancreatic cancer. Methods: Based on a literature review of RCTs (2006RCTs ( -2009, we identified survival endpoints and events currently used. A 2-round modified Delphi method using RAND scoring (range:1-9) was used to reach consensus. Academic research groups were contacted for participation in order to select clinicians and methodologists for Pilot and Scoring groups (>30 experts/localization). Results: The Pilot group identified 14 endpoints that needed definition through consensus, such as progression free survival (PFS), time-to-treatment failure, and time to quality of life deterioration. Endpoint definitions were seeked by disease setting (detectable disease vs not). Amongst the 52 European experts contacted, 33 and 30 participated to the 1st and 2nd round respectively. The experts scored a total of 204 events; a consensus was reached for 25 (12%) at the 1st round and 156 (76%) at the 2nd round. As example PFS was defined as time interval between the date of randomization, and the day of first local, regional progression or occurrence of distant metastases (including liver or non-liver metastases) or occurrence of 2nd pancreatic cancer or death (all causes), whichever occurred first. The consensus was finalized during a face-to-face meeting organized during the ESMO 2011 congress and general rules were proposed for final ratification. Conclusion: Based on this consensus, a European charter is being finalized and proposed for endorsement to all academic groups in order to harmonize results and to allow formal comparisons of pancreatic RCTs. The impact of these definitions on trial results will be also investigated in a further project. GlobeImmune, Inc., Louisville, CO Introduction: Patients with resected pancreas cancer treated with standard of care gemcitabine have a median overall survival of 22 months (vs 20 months with observation). Activating mutations in ras occur in > 90% of pancreas cancer cases. GI-4000 is a proprietary immunotherapy designed to target cells with activating ras mutations using whole, heat-killed recombinant Saccharomyces cerevisiae yeast (called Tarmogens = Targeted Molecular Immunogens). Tarmogens have demonstrated selective killing of target cells expressing a number of cancer antigens including mutated Ras in vivo by activating an antigen-specific T cell mediated response. This trial is designed to evaluate the efficacy, immunogenicity, and safety of GI-4000 plus gemcitabine in patients with Ras mutant positive resected pancreas cancer. Methods: The study enrolled 176 subjects with Ras mutant positive adenoca...