dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Walma, M. S. |
dc.contributor.author | Rombouts, S. J. |
dc.contributor.author | Brada, L. J. H. |
dc.contributor.author | Borel Rinkes, I. H. |
dc.contributor.author | Bosscha, K. |
dc.contributor.author | Bruijnen, R. C. |
dc.contributor.author | Pando Rau, Elizabeth |
dc.date.accessioned | 2021-12-28T10:23:02Z |
dc.date.available | 2021-12-28T10:23:02Z |
dc.date.issued | 2021-04-29 |
dc.identifier.citation | Walma MS, Rombouts SJ, Brada LJH, Borel Rinkes IH, Bosscha K, Bruijnen RC, et al. Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial. Trials. 2021 Apr 29;22:313. |
dc.identifier.issn | 1745-6215 |
dc.identifier.uri | https://hdl.handle.net/11351/6750 |
dc.description | Chemotherapy; Locally advanced pancreatic cancer; Radiofrequency ablation |
dc.description.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. |
dc.language.iso | eng |
dc.publisher | BMC |
dc.relation.ispartofseries | Trials;22 |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Pàncrees - Càncer - Tractament |
dc.subject | Extirpació (Cirurgia) |
dc.subject | Quimioteràpia |
dc.subject.mesh | Radiofrequency Ablation |
dc.subject.mesh | Pancreatic Neoplasms |
dc.subject.mesh | /therapy |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols |
dc.title | Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1186/s13063-021-05248-y |
dc.subject.decs | ablación por radiofrecuencia |
dc.subject.decs | neoplasias pancreáticas |
dc.subject.decs | /terapia |
dc.subject.decs | protocolos de quimioterapia antineoplásica combinada |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Walma MS, Rombouts SJ, Brada LJH] 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. Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. [Borel Rinkes IH, Bruijnen RC] 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. [Bosscha K] Departments of Surgery and Medical Oncology, Jeroen Bosch Hospital, ‘s-Hertogenbosch, The Netherlands. [Pando E] Servei de Cirurgia Hepatobiliopancreàtica i Trasplantaments, Vall d’Hebron Hospital Universitari, Barcelona, Spain |
dc.identifier.pmid | 33926539 |
dc.identifier.wos | 000654876700002 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |