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. 2021 Apr 29;22(1):313.
doi: 10.1186/s13063-021-05248-y.

Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial

M S Walma #  1   2 , S J Rombouts #  3   4 , L J H Brada #  3   4 , I H Borel Rinkes  3 , K Bosscha  5 , R C Bruijnen  3 , O R Busch  4 , G J Creemers  6 , F Daams  4 , R M van Dam  7 , O M van Delden  4 , S Festen  8 , P Ghorbani  9 , D J de Groot  10 , J W B de Groot  11 , N Haj Mohammad  3 , R van Hillegersberg  3 , I H de Hingh  6 , M D'Hondt  12 , E D Kerver  8 , M S van Leeuwen  3 , M S Liem  13 , K P van Lienden  4 , M Los  3 , V E de Meijer  10 , M R Meijerink  4 , L J Mekenkamp  13 , C Y Nio  4 , I Oulad Abdennabi  4 , E Pando  14 , G A Patijn  11 , M B Polée  15 , J F Pruijt  5 , G Roeyen  16 , J A Ropela  17 , M W J Stommel  18 , J de Vos-Geelen  7 , J J de Vries  4 , E M van der Waal  3 , F J Wessels  3 , J W Wilmink  4 , H C van Santvoort #  3 , M G Besselink #  4 , I Q Molenaar #  19 ; Dutch Pancreatic Cancer Group
Affiliations

Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial

M S Walma et al. Trials. .

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: Chemotherapy; Locally advanced pancreatic cancer; Overall survival; Radiofrequency ablation.

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Conflict of interest statement

JWdG has received personal fees outside the submitted work from Bristol-Myers Squibb, Roche, Pierre-Fabre, Servier, MSD, and Novartis. RvH is a proctor for Intuitive, is part of the advisory board of Medtronics, and received an educational grant from Olympus outside the submitted work. IdH reports grants from Roche Pharmaceutical, QPS/RanD, and Medtronic, outside the submitted work. KvL reports personal fees and non-financial support from AngioDynamics, outside the submitted work. VEdM reports grants from Stichting Louise Vehmeijer and NWO and travel grants from Astellas and Neovii, outside the submitted work. MRM reports grants, personal fees, and non-financial support from Angiodynamics; grants and personal fees from Medtronic Covidien; and non-financial support from Cascination, outside the submitted work. NHM reports advisory board fees for her institution from BMS, Eli Lilly, Servier, and MSD. JdVG reports grants and non-financial support from Servier, outside the submitted work. JWW reports research grants from Servier, Halozyme, Novartis, Celgene, Astra Zeneca, Pfizer, Roche, Amgen, and Merck and a consulting/advisory role for Servier and Celgene. HCvS has received a research grant from the Dutch Cancer Society, during and outside the submitted work. MGB has received a research grant from the Dutch Cancer Society, during and outside the conduct of the study. IQM has received a research grant from the Dutch Cancer Society, during the conduct of the study. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial flow diagram
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments according to the SPIRIT guidelines
See this image and copyright information in PMC

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