GARIBALDI - PANCREOS. Michele Reni OVERVIEW DAGLI STUDI CLINICI CON NAB-PACLITAXEL

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1 OVERVIEW DAGLI STUDI CLINICI CON NAB-PACLITAXEL GARIBALDI - PANCREOS Michele Reni Direttore di Programma Strategico Pancreas Translational and Clinical Research Center

2 A call to action. European Parliament 12nd november 2014 Ensuring pancreatic cancer is included in key European initiatives aiming at fighting cancer, with a focus on: 1. increasing research to better understand the disease 2. improving data collection -registries 3. identifying tools for earlier diagnosis 4. providing educational programmes 5. improving standard of care with a focus on active treatment Ensuring that Member States include PC in their national cancer plans and in their health awareness programmes. Philippe de Backer, Françoise Grossetête,Philippe Juvinand Daciana Sârbu. November 2014 PARLIAMENTMAGAZINE

3 Increase the knowledge base that is used to inform clinical & translational research in pancreatic cancer Develop the largest EU-based PC registry Gather information relating to all aspects of the management of patients with PC from initial diagnosis and throughout the treatment continuum Generate a large, robust database Netheralnd s France Spain Germany (PMS) Greece UK Europe Austria NIS Portugal Italy Inform experts involved in treatment guidelines Raise awareness of current treatment trends and their impact on OS

4 Pancreatic cancer research needs to focus on multiple aspects to improve the disease outcome Identify earlier and faster detection tools Training & education of primary care physicians to improve familiarity with early symptoms Reduce the time from diagnosis to treatment Improved diagnostics Better understanding of basic biology and aetiology of PC Develop scientific model systems Greater R&D support activities EU AND NATIONAL RESEARCH Better understanding of genomics Identify potential biomarkers Understand resistance to some chemotherapies PROGRAMMES Establishment and maintenance of patients registries Improved data collection processes Better patient management New clinical treatment Need for more clinical development programs for new drugs Improving the standard of care from purely palliation to active treatment 29.

5 Grupo de Tratamiento de los Tumores Digestivos PANCREOS SPAIN Study title: Clinical profile and therapeutic management of patients with PC; a Registry in Medical Oncology Hospital Services in SPAIN. PANCREOS-SPAIN Disease/population: Patients with pancreatic cancer at any stage. Kind of study: National registry. Epidemiological, observational and prospective Study Registry study. Hospital clinical practice. Sponsor: TTD IP: Dr. Carrato Hospital Universitario Ramón y Cajal, Madrid. CRO: Pivotal S.L Stage I-Pilot 7 centers 70 patients (estimation) Period of time: 4 months Stage 2- Registry expansion 15 centers 600 patients (estimation) Period of time: up to 3 years ACCRUAL TIME: FPI: September 2014 LPI: September 2017 LPLV: September 2017 Period of time: 3 years

6 - GARIBALDI Guidelines Application in Real world: a multi- Institution Based survey of Adjuvant and first-line pancreatic Ductal adenocarcinoma treatment in Italy GARIBALDI

7 PRIMARY OBJECTIVE Ø Ø describe the pattern of treatment for patients undergoing a 1 st -line therapy evaluate the agreement with national recommendations

8 SECONDARY OBJECTIVES Ø Ø OS PFS

9 ELIGIBILITY CRITERIA - I chemo- and radio- naïve patients any pathological diagnosis of PDAC (but pnet) management in the participating institution no limits of stage, age, PS, and treatment

10 ELIGIBILITY CRITERIA - II participating institutions representing different geographical and expertise areas: high-volume centers with > 50 treated pts/year; medium-volume centers with pts/year; low-volume centers with < 25 pts/year.

11 STATISTICS - Approximately 1000 pts - Accrual period 1yr - Sample size not based on formal hypothesis testing - Separate analysis by each of the 3 pts groups - Analysis of agreement with Guidelines as function of pt (age, sex, comorbidity, PS..) and clinic characteristics (experience of operator, dedicated units, number of pts treated/y, academic/research centers )