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

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العنوان: Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial
المؤلفون: Mathieu D'Hondt, Sebastiaan Festen, Rutger C G Bruijnen, O.M. van Delden, E. M. van der Waal, I.H.J.T. de Hingh, J. A. Ropela, J. de Vos-Geelen, Johanna W. Wilmink, Chung Y. Nio, R.M. van Dam, Derk Jan A. de Groot, Geert Roeyen, J.W.B. de Groot, K.P. van Lienden, N. Haj Mohammad, S. J. Rombouts, O.R.C. Busch, Lilly J H Brada, G.J.M. Creemers, M. Liem, Gijs A. Patijn, J. de Vries, F. Daams, I.Q. Molenaar, V. E. de Meijer, M. S. van Leeuwen, Maartje Los, Leonie J. M. Mekenkamp, M.S. Walma, I. Oulad Abdennabi, P. Ghorbani, Martijn W J Stommel, H.C. van Santvoort, Elizabeth Pando, Emile D. Kerver, I. H. M. Borel Rinkes, J.F.M. Pruijt, R. van Hillegersberg, Koop Bosscha, Frank J. Wessels, Martijn R. Meijerink, Marc G. Besselink, Marco B. Polee
المساهمون: Dutch Pancreatic Cancer Group, Surgery, CCA - Cancer Treatment and quality of life, Amsterdam Gastroenterology Endocrinology Metabolism, Radiology and nuclear medicine, Internal medicine, MUMC+: MA Heelkunde (9), Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Groningen Institute for Organ Transplantation (GIOT), Center for Liver, Digestive and Metabolic Diseases (CLDM), Institut Català de la Salut, [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, Vall d'Hebron Barcelona Hospital Campus, CCA - Cancer Treatment and Quality of Life, Radiology and Nuclear Medicine, Amsterdam Cardiovascular Sciences, Cancer Center Amsterdam, Laboratory for General Clinical Chemistry, Oncology
المصدر: Trials, 22, 1
Trials
Trials, 22
Trials, 22(1):313. BioMed Central
Dutch Pancreatic Cancer Group 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
Trials, 22(1):313. BioMed Central Ltd
TRIALS, 22(1):313, 1-12. BMC
Scientia
Trials, Vol 22, Iss 1, Pp 1-12 (2021)
سنة النشر: 2021
مصطلحات موضوعية: Oncology, Medicine (General), Radiofrequency ablation, FOLFIRINOX, SURGERY, medicine.medical_treatment, Locally advanced pancreatic cancer, INTERNATIONAL STUDY-GROUP, Medicine (miscellaneous), 030230 surgery, law.invention, Study Protocol, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 0302 clinical medicine, Randomized controlled trial, law, Antineoplastic Combined Chemotherapy Protocols, Quimioteràpia, Clinical endpoint, Multicenter Studies as Topic, Pharmacology (medical), Overall survival, neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas [ENFERMEDADES], Otros calificadores::/terapia [Otros calificadores], Netherlands, Randomized Controlled Trials as Topic, terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Extirpació (Cirurgia), TUMORS, Progression-Free Survival, 030220 oncology & carcinogenesis, SURVIVAL, terapéutica::tratamiento de radiofrecuencia::ablación por radiofrecuencia [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], medicine.drug, medicine.medical_specialty, CLINICAL-OUTCOMES, Therapeutics::Radiofrequency Therapy::Radiofrequency Ablation [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], 03 medical and health sciences, R5-920, Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Internal medicine, Pancreatic cancer, Pàncrees - Càncer - Tractament, medicine, Humans, Chemotherapy, Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms [DISEASES], business.industry, Cancer, ADENOCARCINOMA, Other subheadings::/therapy [Other subheadings], medicine.disease, PHASE-III, Gemcitabine, Pancreatic Neoplasms, DEFINITION, GEMCITABINE, Human medicine, business
الوصف: 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 RegistryNL4997. Registered on December 29, 2015. ClinicalTrials.govNCT03690323. Retrospectively registered on October 1, 2018
وصف الملف: application/pdf
تدمد: 1745-6215
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d3471da294f3f1dbd689adeaf8e6be22
https://repository.ubn.ru.nl/handle/2066/239066
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....d3471da294f3f1dbd689adeaf8e6be22
قاعدة البيانات: OpenAIRE
الوصف
تدمد:17456215