protocolSection identificationModule nctId: NCT06366828, orgStudyIdInfo id: 11446, briefTitle: Prediction Models for Complications After CRT in Esophageal Cancer, acronym: MODELS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2030-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: Dutch Cancer Society, collaborators name: Comprehensive Cancer Centre The Netherlands, collaborators name: Dutch Institute for Clinical Auditing (DICA), collaborators name: ZorgTTP, descriptionModule briefSummary: The aim of this project is to develop and validate NTCP-models for complications after nCRT (and surgical resection), that can be uses for model-based dose optimization for PhRT and PRT, and for model-based selection for PRT, in patients with esophageal cancer, conditionsModule conditions: The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: retrospective, outcomesModule primaryOutcomes measure: Multivariable NTCP models will be developed for the prediction of the following, primaryOutcomes measure: Cardiac events grade II or higher (CTCAE v 5.0), including:, primaryOutcomes measure: Mortality, primaryOutcomes measure: Complication Sum Score, that will be determined in Delphi consensus, secondaryOutcomes measure: Patient-rated dysphagia, secondaryOutcomes measure: Patient-rated nausea, secondaryOutcomes measure: Patient-rated fatigue / daily functioning, secondaryOutcomes measure: Hospitalization after esophagectomy (days), secondaryOutcomes measure: Intensive care unit stay after esophagectomy (days), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboud UMC, status: RECRUITING, city: Nijmegen, state: Gelderland, zip: 6525GA, country: Netherlands, contacts name: H. Rutten, MD, role: CONTACT, geoPoint lat: 51.8425, lon: 5.85278, locations facility: Maastro clinic, status: RECRUITING, city: Maastricht, state: Limburg, zip: 6229ET, country: Netherlands, contacts name: M. Berbee, MD, PHD, role: CONTACT, geoPoint lat: 50.84833, lon: 5.68889, locations facility: Amsterdam UMC, status: RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1105AZ, country: Netherlands, contacts name: P. van Rossum, MD, PHD, role: CONTACT, contacts name: H.W.M. van Laarhoven, MD, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Erasmus MC, status: RECRUITING, city: Rotterdam, state: Zuid-Holland, zip: 3015GE, country: Netherlands, contacts name: J. Nuyttens, MD, PHD, role: CONTACT, contacts name: B. Wijnhoven, MD, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Holland PTC, status: NOT_YET_RECRUITING, city: Delft, country: Netherlands, contacts name: Yvonne Klaver, MD, PHD, role: CONTACT, geoPoint lat: 52.00667, lon: 4.35556, locations facility: UMCG, status: RECRUITING, city: Groningen, zip: 9715GZ, country: Netherlands, contacts name: Christina Muijs, MD, PHD, role: CONTACT, phone: 0503616161, email: c.t.muijs@umcg.nl, contacts name: C. T. Muijs, MD, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: J. A. Langendijk, Prof., MD, PHD, role: SUB_INVESTIGATOR, contacts name: B. van Etten, MD, PHD, role: SUB_INVESTIGATOR, contacts name: J. J. de Haan, MD, PHD, role: SUB_INVESTIGATOR, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Zuyderland hospital, status: RECRUITING, city: Heerlen, country: Netherlands, contacts name: Meindert Sosef, MD, role: CONTACT, geoPoint lat: 50.88365, lon: 5.98154, locations facility: UMCU, status: RECRUITING, city: Utrecht, zip: 3584CX, country: Netherlands, contacts name: G Meijer, PHD, role: CONTACT, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False