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