M S Walma1,2, S J Rombouts3,4, L J H Brada3,4, H C van Santvoort3, M G Besselink4, I Q Molenaar5, I H Borel Rinkes3, K Bosscha6, R C Bruijnen3, O R Busch4, G J Creemers7, F Daams4, R M van Dam8, O M van Delden4, S Festen9, P Ghorbani10, D J de Groot11, J W B de Groot12, N Haj Mohammad3, R van Hillegersberg3, I H de Hingh7, M D'Hondt13, E D Kerver9, M S van Leeuwen3, M S Liem14, K P van Lienden4, M Los3, V E de Meijer11, M R Meijerink4, L J Mekenkamp14, C Y Nio4, I Oulad Abdennabi4, E Pando15, G A Patijn12, M B Polée16, J F Pruijt6, G Roeyen17, J A Ropela18, M W J Stommel19, J de Vos-Geelen8, J J de Vries4, E M van der Waal3, F J Wessels3, J W Wilmink4. 1. Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. m.s.walma@umcutrecht.nl. 2. Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. m.s.walma@umcutrecht.nl. 3. Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. 4. Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. 5. Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. i.q.molenaar@umcutrecht.nl. 6. Departments of Surgery and Medical Oncology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands. 7. Departments of Surgery and Medical Oncology, Catharina Hospital, Eindhoven, The Netherlands. 8. Departments of Surgery and Medical Oncology GROW - School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, The Netherlands. 9. Departments of Surgery and Medical Oncology, OLVG, Amsterdam, The Netherlands. 10. Pancreatic Surgery Unit, Division of Surgery, CLINTEC, Karolinska Institute at Center for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden. 11. Departments of Surgery and Medical Oncology, UMC Groningen, Groningen, The Netherlands. 12. Departments of Surgery and Medical Oncology, Isala, Zwolle, The Netherlands. 13. Department of General and Digestive Surgery, Groeninge Hospital, Kortrijk, Belgium. 14. Departments of Surgery and Medical Oncology, Medical Spectrum Twente, Enschede, The Netherlands. 15. HBP Surgery and Transplant Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain. 16. Department of Medical Oncology, Medical Center Leeuwarden, Leeuwarden, The Netherlands. 17. Department of Hepatobiliary, Endocrine and Transplantation Surgery, Antwerp University Hospital, Antwerp, Belgium. 18. Department of Medical Oncology, St Jansdal Hospital, Harderwijk, The Netherlands. 19. Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
Abstract
BACKGROUND: Approximately 80% of patients with locally advanced pancreatic cancer (LAPC) are treated with chemotherapy, of whom approximately 10% undergo a resection. Cohort studies investigating local tumor ablation with radiofrequency ablation (RFA) have reported a promising overall survival of 26-34 months when given in a multimodal setting. However, randomized controlled trials (RCTs) investigating the effect of RFA in combination with chemotherapy in patients with LAPC are lacking. METHODS: The "Pancreatic Locally Advanced Unresectable Cancer Ablation" (PELICAN) trial is an international multicenter superiority RCT, initiated by the Dutch Pancreatic Cancer Group (DPCG). All patients with LAPC according to DPCG criteria, who start with FOLFIRINOX or (nab-paclitaxel/)gemcitabine, are screened for eligibility. Restaging is performed after completion of four cycles of FOLFIRINOX or two cycles of (nab-paclitaxel/)gemcitabine (i.e., 2 months of treatment), and the results are assessed within a nationwide online expert panel. Eligible patients with RECIST stable disease or objective response, in whom resection is not feasible, are randomized to RFA followed by chemotherapy or chemotherapy alone. In total, 228 patients will be included in 16 centers in The Netherlands and four other European centers. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, RECIST response, CA 19.9 and CEA response, toxicity, quality of life, pain, costs, and immunomodulatory effects of RFA. DISCUSSION: The PELICAN RCT aims to assess whether the combination of chemotherapy and RFA improves the overall survival when compared to chemotherapy alone, in patients with LAPC with no progression of disease following 2 months of systemic treatment. TRIAL REGISTRATION: Dutch Trial Registry NL4997 . Registered on December 29, 2015. ClinicalTrials.gov NCT03690323 . Retrospectively registered on October 1, 2018.
RCT Entities:
BACKGROUND: Approximately 80% of patients with locally advanced pancreatic cancer (LAPC) are treated with chemotherapy, of whom approximately 10% undergo a resection. Cohort studies investigating local tumor ablation with radiofrequency ablation (RFA) have reported a promising overall survival of 26-34 months when given in a multimodal setting. However, randomized controlled trials (RCTs) investigating the effect of RFA in combination with chemotherapy in patients with LAPC are lacking. METHODS: The "Pancreatic Locally Advanced Unresectable Cancer Ablation" (PELICAN) trial is an international multicenter superiority RCT, initiated by the Dutch Pancreatic Cancer Group (DPCG). All patients with LAPC according to DPCG criteria, who start with FOLFIRINOX or (nab-paclitaxel/)gemcitabine, are screened for eligibility. Restaging is performed after completion of four cycles of FOLFIRINOX or two cycles of (nab-paclitaxel/)gemcitabine (i.e., 2 months of treatment), and the results are assessed within a nationwide online expert panel. Eligible patients with RECIST stable disease or objective response, in whom resection is not feasible, are randomized to RFA followed by chemotherapy or chemotherapy alone. In total, 228 patients will be included in 16 centers in The Netherlands and four other European centers. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, RECIST response, CA 19.9 and CEA response, toxicity, quality of life, pain, costs, and immunomodulatory effects of RFA. DISCUSSION: The PELICAN RCT aims to assess whether the combination of chemotherapy and RFA improves the overall survival when compared to chemotherapy alone, in patients with LAPC with no progression of disease following 2 months of systemic treatment. TRIAL REGISTRATION: Dutch Trial Registry NL4997 . Registered on December 29, 2015. ClinicalTrials.gov NCT03690323 . Retrospectively registered on October 1, 2018.
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