AIMS - This trial aims to evaluate complete resection rates (R0) with the addition of pre-operativechemotherapy in pancreatic cancer. It also aims to define surrogate endpoints of response to pre-operativechemotherapy. In addition, the trial seeks to carefully define treatment-related toxicity and treatment failure.BACKGROUND - Over 2500 Australians are diagnosed with pancreatic cancer each year, making researchin this disease a high priority. The 5-year survival of patients undergoing surgery is still low at 20% despiteimprovements of surgical care and the addition of adjuvant therapy. Local and distant recurrence arefrequent problems following resection of pancreas adenocarcinoma with curative intent. As a result, adjuvantand neoadjuvant protocols using radiotherapy (RT), chemotherapy (CT), or multimodality treatment havebeen investigated.Both Palmer and Heinrich showed promising overall survival (OS) [62% 12 month survival and 26.5 monthsOS respectively] after neoadjuvant chemotherapy with a high percentage of patients able to proceed tosurgery [62% and 80%]. The recent data presented by Von Hoff et al. suggests that the combination ofgemcitabine and Abraxane (nab-paclitaxel) represents a major enhancement in response [58%] and overallsurvival (12.2 months) in the first line setting. Neoadjuvant therapy is able to identify patients with aggressivetumour biology who may be spared the morbidity of resection while also identifying those patients most likelyto benefit from radical therapy.Recent data from the New South Wales Pancreatic Cancer Network clearly demonstrated poorer survivalamong 132/365 (35%) patients with R1 resections. The administration of pre-operative CT has beenpostulated as a factor that may affect the prognostic significance of margin status. Studies from the MDAnderson Cancer Center suggest a treatment effect of >50% in the specimen can be considered a responseto treatment. Further exploration regarding the validity of these histological surrogate endpoints is required inaddition to surrogate endpoints for the development of future clinical trials, including candidates such asCa19.9 and FDG-PET.STUDY DESIGN - Non-randomised phase II study with parallel arms post-surgery based on resectionoutcome at surgery. The study will require 50 patients to be registered in total from approximately 14 sites inAustralia. Patients will be accrued over 2.5 years and followed up for a minimum of 12 months.www.agitg.org.au Page | 47STUDY PROGRESS - The study opened to recruitment on the 29th June 2012. At present, there are 11 sitesopen to recruitment with a further three to open in the near future. To date 22 patients have been registeredto the study. Of these 22 patients, 13 have reached the surgery time point with 12 patients subsequentlyundergoing surgery and one patient refusing surgery.To date no major treatment related complications and no unexpected delays in timing of surgery have beenseen.TRANSLATIONAL - GAP-T - NHMRC project grant to support biological and PET sub-study was awarded inOctober 2011.The following are being collected from all patients to answer the tertiary objectives of the study.Tissue sample collection: Collected at baseline and at surgery for central histopathological review: to definehistopathological response criteria; and for biomarker research (potential prognostic or predictive factors forstudy endpoints).Blood sample collection: Collected at baseline and at surgery. Serum, plasma, red cell pellet and buffy coatwill be recovered from the peripheral blood for biomarker research (potential prognostic or predictive factorsfor study endpoints).Also, PET scans – are performed at baseline (pre-commencement of neoadjuvant therapy) and Cycle 1 Day15 (+/- 1 day) of neoadjuvant chemotherapy. This is to investigate utility of change in SUVmax of FDG-PETas: a prognostic factor for survival, a predictive factor for histopathological response and resection marginstatus (R0 vs R1).