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. Polee; 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; Dutch Pancreatic Canc Grp

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^*, 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. KerverM. 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. Polee, 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^*, Dutch Pancreatic Canc Grp

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Article number	313
Number of pages	12
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05248-y
Publication status	Published - 29 Apr 2021

Keywords

Locally advanced pancreatic cancer
Radiofrequency ablation
Chemotherapy
Overall survival
INTERNATIONAL STUDY-GROUP
CLINICAL-OUTCOMES
PHASE-III
GEMCITABINE
DEFINITION
SURVIVAL
ADENOCARCINOMA
FOLFIRINOX
SURGERY
TUMORS

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Walma, M. S., Rombouts, S. J., Brada, L. J. H., Borel Rinkes, I. H., Bosscha, K., Bruijnen, R. C., Busch, O. R., Creemers, G. J., Daams, F., van Dam, R. M., van Delden, O. M., Festen, S., Ghorbani, P., de Groot, D. J., de Groot, J. W. B., Haj Mohammad, N., van Hillegersberg, R., de Hingh, I. H., D'Hondt, M., ... Dutch Pancreatic Canc Grp (2021). Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial. Trials, 22(1), Article 313. https://doi.org/10.1186/s13063-021-05248-y

@article{5344802802094e208b945d968a5aa313,

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

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.",

keywords = "Locally advanced pancreatic cancer, Radiofrequency ablation, Chemotherapy, Overall survival, INTERNATIONAL STUDY-GROUP, CLINICAL-OUTCOMES, PHASE-III, GEMCITABINE, DEFINITION, SURVIVAL, ADENOCARCINOMA, FOLFIRINOX, SURGERY, TUMORS",

author = "Walma, {M. S.} and Rombouts, {S. J.} and Brada, {L. J. H.} and {Borel Rinkes}, {I. H.} and K. Bosscha and Bruijnen, {R. C.} and Busch, {O. R.} and Creemers, {G. J.} and F. Daams and {van Dam}, {R. M.} and {van Delden}, {O. M.} and S. Festen and P. Ghorbani and {de Groot}, {D. J.} and {de Groot}, {J. W. B.} and {Haj Mohammad}, N. and {van Hillegersberg}, R. and {de Hingh}, {I. H.} and M. D'Hondt and Kerver, {E. D.} and {van Leeuwen}, {M. S.} and Liem, {M. S.} and {van Lienden}, {K. P.} and M. Los and {de Meijer}, {V. E.} and Meijerink, {M. R.} and Mekenkamp, {L. J.} and Nio, {C. Y.} and {Oulad Abdennabi}, I. and E. Pando and Patijn, {G. A.} and Polee, {M. B.} and Pruijt, {J. F.} and G. Roeyen and Ropela, {J. A.} and Stommel, {M. W. J.} and {de Vos-Geelen}, J. and {de Vries}, {J. J.} and {van der Waal}, {E. M.} and Wessels, {F. J.} and Wilmink, {J. W.} and {van Santvoort}, {H. C.} and Besselink, {M. G.} and Molenaar, {I. Q.} and {Dutch Pancreatic Canc Grp}",

year = "2021",

month = apr,

day = "29",

doi = "10.1186/s13063-021-05248-y",

language = "English",

volume = "22",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

number = "1",

}

Walma, MS, Rombouts, SJ, Brada, LJH, Borel Rinkes, IH, Bosscha, K, Bruijnen, RC, Busch, OR, Creemers, GJ, Daams, F, van Dam, RM, van Delden, OM, Festen, S, Ghorbani, P, de Groot, DJ, de Groot, JWB, Haj Mohammad, N, van Hillegersberg, R, de Hingh, IH, D'Hondt, M, Kerver, ED, van Leeuwen, MS, Liem, MS, van Lienden, KP, Los, M, de Meijer, VE, Meijerink, MR, Mekenkamp, LJ, Nio, CY, Oulad Abdennabi, I, Pando, E, Patijn, GA, Polee, MB, Pruijt, JF, Roeyen, G, Ropela, JA, Stommel, MWJ, de Vos-Geelen, J, de Vries, JJ, van der Waal, EM, Wessels, FJ, Wilmink, JW, van Santvoort, HC, Besselink, MG, Molenaar, IQ & Dutch Pancreatic Canc Grp 2021, 'Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial', Trials, vol. 22, no. 1, 313. https://doi.org/10.1186/s13063-021-05248-y

TY - JOUR

T1 - Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN)

T2 - study protocol for a randomized controlled trial

AU - Walma, M. S.

AU - Rombouts, S. J.

AU - Brada, L. J. H.

AU - Borel Rinkes, I. H.

AU - Bosscha, K.

AU - Bruijnen, R. C.

AU - Busch, O. R.

AU - Creemers, G. J.

AU - Daams, F.

AU - van Dam, R. M.

AU - van Delden, O. M.

AU - Festen, S.

AU - Ghorbani, P.

AU - de Groot, D. J.

AU - de Groot, J. W. B.

AU - Haj Mohammad, N.

AU - van Hillegersberg, R.

AU - de Hingh, I. H.

AU - D'Hondt, M.

AU - Kerver, E. D.

AU - van Leeuwen, M. S.

AU - Liem, M. S.

AU - van Lienden, K. P.

AU - Los, M.

AU - de Meijer, V. E.

AU - Meijerink, M. R.

AU - Mekenkamp, L. J.

AU - Nio, C. Y.

AU - Oulad Abdennabi, I.

AU - Pando, E.

AU - Patijn, G. A.

AU - Polee, M. B.

AU - Pruijt, J. F.

AU - Roeyen, G.

AU - Ropela, J. A.

AU - Stommel, M. W. J.

AU - de Vos-Geelen, J.

AU - de Vries, J. J.

AU - van der Waal, E. M.

AU - Wessels, F. J.

AU - Wilmink, J. W.

AU - van Santvoort, H. C.

AU - Besselink, M. G.

AU - Molenaar, I. Q.

AU - Dutch Pancreatic Canc Grp

PY - 2021/4/29

Y1 - 2021/4/29

N2 - 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.

AB - 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.

KW - Locally advanced pancreatic cancer

KW - Radiofrequency ablation

KW - Chemotherapy

KW - Overall survival

KW - INTERNATIONAL STUDY-GROUP

KW - CLINICAL-OUTCOMES

KW - PHASE-III

KW - GEMCITABINE

KW - DEFINITION

KW - SURVIVAL

KW - ADENOCARCINOMA

KW - FOLFIRINOX

KW - SURGERY

KW - TUMORS

U2 - 10.1186/s13063-021-05248-y

DO - 10.1186/s13063-021-05248-y

M3 - Article

C2 - 33926539

SN - 1745-6215

VL - 22

JO - Trials

JF - Trials

IS - 1

M1 - 313

ER -

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

Abstract

Keywords

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