Trials (Apr 2021)
Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial
- M. S. Walma,
- S. J. Rombouts,
- L. J. H. Brada,
- I. H. Borel Rinkes,
- K. Bosscha,
- R. C. Bruijnen,
- O. R. Busch,
- G. J. Creemers,
- F. Daams,
- R. M. van Dam,
- O. M. van Delden,
- S. Festen,
- P. Ghorbani,
- D. J. de Groot,
- J. W. B. de Groot,
- N. Haj Mohammad,
- R. van Hillegersberg,
- I. H. de Hingh,
- M. D’Hondt,
- E. D. Kerver,
- M. S. van Leeuwen,
- M. S. Liem,
- K. P. van Lienden,
- M. Los,
- V. E. de Meijer,
- M. R. Meijerink,
- L. J. Mekenkamp,
- C. Y. Nio,
- I. Oulad Abdennabi,
- E. Pando,
- G. A. Patijn,
- M. B. Polée,
- J. F. Pruijt,
- G. Roeyen,
- J. A. Ropela,
- M. W. J. Stommel,
- J. de Vos-Geelen,
- J. J. de Vries,
- E. M. van der Waal,
- F. J. Wessels,
- J. W. Wilmink,
- H. C. van Santvoort,
- M. G. Besselink,
- I. Q. Molenaar,
- for the Dutch Pancreatic Cancer Group
Affiliations
- M. S. Walma
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- S. J. Rombouts
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- L. J. H. Brada
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- I. H. Borel Rinkes
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- K. Bosscha
- Departments of Surgery and Medical Oncology, Jeroen Bosch Hospital
- R. C. Bruijnen
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- O. R. Busch
- Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- G. J. Creemers
- Departments of Surgery and Medical Oncology, Catharina Hospital
- F. Daams
- Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- R. M. van Dam
- Departments of Surgery and Medical Oncology GROW – School for Oncology and Developmental Biology, Maastricht UMC+
- O. M. van Delden
- Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- S. Festen
- Departments of Surgery and Medical Oncology, OLVG
- P. Ghorbani
- Pancreatic Surgery Unit, Division of Surgery, CLINTEC, Karolinska Institute at Center for Digestive Diseases, Karolinska University Hospital
- D. J. de Groot
- Departments of Surgery and Medical Oncology, UMC Groningen
- J. W. B. de Groot
- Departments of Surgery and Medical Oncology, Isala
- N. Haj Mohammad
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- R. van Hillegersberg
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- I. H. de Hingh
- Departments of Surgery and Medical Oncology, Catharina Hospital
- M. D’Hondt
- Department of General and Digestive Surgery, Groeninge Hospital
- E. D. Kerver
- Departments of Surgery and Medical Oncology, OLVG
- M. S. van Leeuwen
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- M. S. Liem
- Departments of Surgery and Medical Oncology, Medical Spectrum Twente
- K. P. van Lienden
- Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- M. Los
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- V. E. de Meijer
- Departments of Surgery and Medical Oncology, UMC Groningen
- M. R. Meijerink
- Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- L. J. Mekenkamp
- Departments of Surgery and Medical Oncology, Medical Spectrum Twente
- C. Y. Nio
- Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- I. Oulad Abdennabi
- Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- E. Pando
- HBP Surgery and Transplant Department, Hospital Universitari Vall d’Hebron
- G. A. Patijn
- Departments of Surgery and Medical Oncology, Isala
- M. B. Polée
- Department of Medical Oncology, Medical Center Leeuwarden
- J. F. Pruijt
- Departments of Surgery and Medical Oncology, Jeroen Bosch Hospital
- G. Roeyen
- Department of Hepatobiliary, Endocrine and Transplantation Surgery, Antwerp University Hospital
- J. A. Ropela
- Department of Medical Oncology, St Jansdal Hospital
- M. W. J. Stommel
- Department of Surgery, Radboud University Medical Center
- J. de Vos-Geelen
- Departments of Surgery and Medical Oncology GROW – School for Oncology and Developmental Biology, Maastricht UMC+
- J. J. de Vries
- Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- E. M. van der Waal
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- F. J. Wessels
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- J. W. Wilmink
- Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- H. C. van Santvoort
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- M. G. Besselink
- Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- I. Q. Molenaar
- Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University
- for the Dutch Pancreatic Cancer Group
- DOI
- https://doi.org/10.1186/s13063-021-05248-y
- Journal volume & issue
-
Vol. 22,
no. 1
pp. 1 – 12
Abstract
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
Keywords
