دورية أكاديمية
Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design.
| العنوان: | Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design. |
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| المؤلفون: | Daamen LA; Department of Surgery, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands.; Division of Imaging, UMC Utrecht Cancer Center, Utrecht University, Utrecht, the Netherlands., van Goor IWJM; Department of Surgery, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands. i.w.j.vangoor-5@umcutrecht.nl.; Department of Radiation Oncology, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands. i.w.j.vangoor-5@umcutrecht.nl., Groot VP; Department of Surgery, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands., Andel PCM; Department of Surgery, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands., Brosens LAA; Department of Pathology, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands.; Department of Pathology, Radboud University Medical Center, Nijmegen, the Netherlands., Busch OR; Amsterdam UMC, Department of Surgery, Location University of Amsterdam, Amsterdam, the Netherlands.; Cancer Center Amsterdam, Amsterdam, the Netherlands., Cirkel GA; Department of Medical Oncology, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center, St. Antonius Hospital Nieuwegein & Meander Medical Center, Utrecht University, Utrecht, the Netherlands., Mohammad NH; Department of Medical Oncology, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center, St. Antonius Hospital Nieuwegein & Meander Medical Center, Utrecht University, Utrecht, the Netherlands., Heerkens HD; Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands., de Hingh IHJT; Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands., Hoogwater F; Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands., van Laarhoven HWM; Cancer Center Amsterdam, Amsterdam, the Netherlands.; Amsterdam UMC, Department of Medical Oncology, Location University of Amsterdam, Amsterdam, the Netherlands., Los M; Department of Medical Oncology, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center, St. Antonius Hospital Nieuwegein & Meander Medical Center, Utrecht University, Utrecht, the Netherlands., Meijer GJ; Department of Radiation Oncology, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands., de Meijer VE; Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands., Pande R; Department of Hepatopancreatobiliary Surgery and Liver Transplantation, Queen Elizabeth Hospital, University Hospitals Birmingham, Birmingham, UK., Roberts KJ; Department of Hepatopancreatobiliary Surgery and Liver Transplantation, Queen Elizabeth Hospital, University Hospitals Birmingham, Birmingham, UK.; Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK., Stoker J; Cancer Center Amsterdam, Amsterdam, the Netherlands.; Amsterdam UMC, Department of Radiology, Location University of Amsterdam, Amsterdam, the Netherlands., Stommel MWJ; Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands., van Tienhoven G; Cancer Center Amsterdam, Amsterdam, the Netherlands.; Amsterdam UMC, Department of Radiation Oncology, Location University of Amsterdam, Amsterdam, the Netherlands., Verdonk RC; Department of Gastroenterology and Hepatology, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands., Verkooijen HM; Division of Imaging, UMC Utrecht Cancer Center, Utrecht University, Utrecht, the Netherlands., Wessels FJ; Department of Radiology, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands., Wilmink JW; Cancer Center Amsterdam, Amsterdam, the Netherlands.; Amsterdam UMC, Department of Medical Oncology, Location University of Amsterdam, Amsterdam, the Netherlands., Besselink MG; Amsterdam UMC, Department of Surgery, Location University of Amsterdam, Amsterdam, the Netherlands.; Cancer Center Amsterdam, Amsterdam, the Netherlands., van Santvoort HC; Department of Surgery, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands., Intven MPW; Department of Radiation Oncology, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands., Molenaar IQ; Department of Surgery, Regional Academic Cancer Center Utrecht, UMC Utrecht Cancer Center & St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands. |
| مؤلفون مشاركون: | Dutch Pancreatic Cancer Group |
| المصدر: | Trials [Trials] 2024 Jun 20; Vol. 25 (1), pp. 401. Date of Electronic Publication: 2024 Jun 20. |
| نوع المنشور: | Clinical Trial Protocol; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BioMed Central, 2006- |
| مواضيع طبية MeSH: | Carcinoma, Pancreatic Ductal*/surgery , Carcinoma, Pancreatic Ductal*/mortality , Carcinoma, Pancreatic Ductal*/diagnostic imaging , Carcinoma, Pancreatic Ductal*/pathology , Carcinoma, Pancreatic Ductal*/blood , Pancreatic Neoplasms*/surgery , Pancreatic Neoplasms*/pathology , Neoplasm Recurrence, Local* , Randomized Controlled Trials as Topic* , Pancreatectomy*/adverse effects , Quality of Life*, Humans ; Time Factors ; Prospective Studies ; Multicenter Studies as Topic ; Treatment Outcome ; Predictive Value of Tests ; Netherlands ; United Kingdom ; Research Design ; Early Detection of Cancer/methods |
| مستخلص: | Background: Disease recurrence remains one of the biggest concerns in patients after resection of pancreatic ductal adenocarcinoma (PDAC). Despite (neo)adjuvant systemic therapy, most patients experience local and/or distant PDAC recurrence within 2 years. High-level evidence regarding the benefits of recurrence-focused surveillance after PDAC resection is missing, and the impact of early detection and treatment of recurrence on survival and quality of life is unknown. In most European countries, recurrence-focused follow-up after surgery for PDAC is currently lacking. Consequently, guidelines regarding postoperative surveillance are based on expert opinion and other low-level evidence. The recent emergence of more potent local and systemic treatment options for PDAC recurrence has increased interest in early diagnosis. To determine whether early detection and treatment of recurrence can lead to improved survival and quality of life, we designed an international randomized trial. Methods: This randomized controlled trial is nested within an existing prospective cohort in pancreatic cancer centers in the Netherlands (Dutch Pancreatic Cancer Project; PACAP) and the United Kingdom (UK) (Pancreas Cancer: Observations of Practice and survival; PACOPS) according to the "Trials within Cohorts" (TwiCs) design. All PACAP/PACOPS participants with a macroscopically radical resection (R0-R1) of histologically confirmed PDAC, who provided informed consent for TwiCs and participation in quality of life questionnaires, are included. Participants randomized to the intervention arm are offered recurrence-focused surveillance, existing of clinical evaluation, serum cancer antigen (CA) 19-9 testing, and contrast-enhanced computed tomography (CT) of chest and abdomen every three months during the first 2 years after surgery. Participants in the control arm of the study will undergo non-standardized clinical follow-up, generally consisting of clinical follow-up with imaging and serum tumor marker testing only in case of onset of symptoms, according to local practice in the participating hospital. The primary endpoint is overall survival. Secondary endpoints include quality of life, patterns of recurrence, compliance to and costs of recurrence-focused follow-up, and the impact on recurrence-focused treatment. Discussion: The RADAR-PANC trial will be the first randomized controlled trial to generate high level evidence for the current clinical equipoise regarding the value of recurrence-focused postoperative surveillance with serial tumor marker testing and routine imaging in patients after PDAC resection. The Trials within Cohort design allows us to study the acceptability of recurrence-focused surveillance among cohort participants and increases the generalizability of findings to the general population. While it is strongly encouraged to offer all trial participants treatment at time of recurrence diagnosis, type and timing of treatment will be determined through shared decision-making. This might reduce the potential survival benefits of recurrence-focused surveillance, although insights into the impact on patients' quality of life will be obtained. Trial Registration: Clinicaltrials.gov, NCT04875325 . Registered on May 6, 2021. (© 2024. The Author(s).) |
| التعليقات: | Erratum in: Trials. 2024 Jul 5;25(1):456. doi: 10.1186/s13063-024-08295-3. (PMID: 38970096) |
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| معلومات مُعتمدة: | WOO 21-03 Deltaplan Alvleesklierkanker |
| فهرسة مساهمة: | Keywords: Disease recurrence; PDAC; Pancreatic cancer; Pancreatic ductal adenocarcinoma; Postoperative surveillance; Quality of life; Survival |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04875325 |
| تواريخ الأحداث: | Date Created: 20240620 Date Completed: 20240621 Latest Revision: 20240705 |
| رمز التحديث: | 20240706 |
| مُعرف محوري في PubMed: | PMC11188210 |
| DOI: | 10.1186/s13063-024-08223-5 |
| PMID: | 38902836 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1745-6215 |
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| DOI: | 10.1186/s13063-024-08223-5 |