Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT06366828
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction Models for Complications After CRT in Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012189', 'term': 'Retrospective Studies'}], 'ancestors': [{'id': 'D016022', 'term': 'Case-Control Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015331', 'term': 'Cohort Studies'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-14', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-04-14', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multivariable NTCP models will be developed for the prediction of the following', 'timeFrame': 'Within 90 days after surgery', 'description': 'Postoperative complications (graded by ECCG classification (3) ):\n\nAtrial fibrillation ≥grade 2\n\nPneumonia ≥grade 2\n\nRespiratory failure requiring re-intubation\n\nAnastomotic leakage ≥ grade 2'}, {'measure': 'Cardiac events grade II or higher (CTCAE v 5.0), including:', 'timeFrame': '1 and 2 year after nCRT', 'description': 'Pericardial effusion\n\nMyocardial infarction and other acute coronary events\n\nHeart failure Pericardial effusion\n\nMyocardial infarction and other acute coronary events\n\nHeart failure\n\nAtrial fibrillation'}, {'measure': 'Mortality', 'timeFrame': '1 and 2 year after nCRT', 'description': 'Mortality'}, {'measure': 'Complication Sum Score, that will be determined in Delphi consensus', 'timeFrame': '1 year after nCRT', 'description': 'Complication Sum Score, that will be determined in Delphi consensus'}], 'secondaryOutcomes': [{'measure': 'Patient-rated dysphagia', 'timeFrame': 'Up to 30 days after nCRT', 'description': 'Patient-rated dysphagia'}, {'measure': 'Patient-rated nausea', 'timeFrame': 'Up to 30 day after nCRT', 'description': 'Patient-rated nausea'}, {'measure': 'Patient-rated fatigue / daily functioning', 'timeFrame': 'Up to 6 months after nCRT', 'description': 'Patient-rated fatigue / daily functioning'}, {'measure': 'Hospitalization after esophagectomy (days)', 'timeFrame': 'Hospitalization after esophagectomy, average 12 days', 'description': 'Hospitalization after esophagectomy (days)'}, {'measure': 'Intensive care unit stay after esophagectomy (days)', 'timeFrame': 'Intensive care unit stay after esophagectomy, average 1.5 days', 'description': 'Intensive care unit stay after esophagectomy (days)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prediction models', 'esophageal cancer (EC)'], 'conditions': ['The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection)']}, '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', 'detailedDescription': 'Plan of investigation\n\nIn the present project we aim to evaluate two potential strategies to predict and consider a broad spectrum of complications for radiotherapy plan optimization and patient selection:\n\nA comprehensive set of separate NTCP-models for several cardiopulmonary and post-operative complications after nCRT, which results in an NTCP-profile.\n\nA single multivariable NTCP-model for a so-called Complication Sum Score (CSS), which is a single composite complication endpoint including all complications after nCRT, weighted depending on severity and impact.\n\nThese prediction models can be used for RT plan optimization and patient selection.\n\nIn order to develop these prediction models the project consortium brings together existing prospective data registries for esophageal cancer, namely the Dutch Upper GI Cancer Audit (DUCA) and the Dutch Cancer Registry (NKR) (as well as the POCOP study).\n\nThe data of these registries will be linked to a retrospective radiotherapy database using the ProTRAIT infrastructure, resulting in a dataset of over 2000 patients.\n\nIn this retrospective cohort study, we will focus on esophageal cancer patients who were treated with nCRT, and for whom an esophagectomy was intended. We will include the patients who received nCRT and the esophagectomy in one of the participating centers. Patients who only received nCRT in one of the participating centers and for whom surgical resection was omitted will be included as well. Detailed eligibility criteria can be found in that section.\n\nEligible patients will be identified by the Dutch Cancer Registry. The surviving patients will be asked to provide informed consent for participation in this study, permission to combine the different data registries and for future use of their data. Patients who died will be included as well, unless they objected agains the use of there data in the participating centers.\n\nOf the participating patients, the radiotherapy plan-CT and treatment plans (i.e. RTplan, RT struct, RT dose), will be pseudo-anonymized, uploaded and transferred to the UMCG data platform, by the participating radiotherapy centers.\n\nA third trusted party, Zorg TTP, will be responsible for the pseudonymization of the three data sources; the Dutch upper GI cancer audit (DUCA), the Dutch Cancer Registry (NKR) and the RTregistry. After that the linkage will be performed at the UMCG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with esophageal cancer, treated with nCRT between 2015-2021 in the participating centers. See eligibility criteria above.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tumor in the esophagus, histologically proven or suspect for esophageal carcinoma\n* WHO performance 0-2\n* Age\\>18years\n* No distant metastasis (M0)\n* Treated with nCRT and planned for or followed by an esophagectomy between 2015 and 2021 in one of the participating centers.\n\nExclusion Criteria:\n\n* Sarcoma, neuro-endocrine or small cell carcinoma of the esophagus\n* Patients who underwent a surgical resection in a non-participating surgical center will be excluded'}, 'identificationModule': {'nctId': 'NCT06366828', 'acronym': 'MODELS', 'briefTitle': 'Prediction Models for Complications After CRT in Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Prediction Models for Complications After CRT in Esophageal Cancer', 'orgStudyIdInfo': {'id': '11446'}}, 'armsInterventionsModule': {'interventions': [{'name': 'retrospective', 'type': 'OTHER', 'description': 'follow up'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'H. Rutten, MD', 'role': 'CONTACT'}], 'facility': 'Radboud UMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '6229ET', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'M. Berbee, MD, PHD', 'role': 'CONTACT'}], 'facility': 'Maastro clinic', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'P. van Rossum, MD, PHD', 'role': 'CONTACT'}, {'name': 'H.W.M. van Laarhoven, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3015GE', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'J. Nuyttens, MD, PHD', 'role': 'CONTACT'}, {'name': 'B. Wijnhoven, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Delft', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Yvonne Klaver, MD, PHD', 'role': 'CONTACT'}], 'facility': 'Holland PTC', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'zip': '9715GZ', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Christina Muijs, MD, PHD', 'role': 'CONTACT', 'email': 'c.t.muijs@umcg.nl', 'phone': '0503616161'}, {'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'}], 'facility': 'UMCG', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Heerlen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Meindert Sosef, MD', 'role': 'CONTACT'}], 'facility': 'Zuyderland hospital', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '3584CX', 'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'G Meijer, PHD', 'role': 'CONTACT'}], 'facility': 'UMCU', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Christina Muijs, Dr.', 'role': 'CONTACT', 'email': 'c.t.muijs@umcg.nl', 'phone': '0503616161'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Cancer Society', 'class': 'OTHER'}, {'name': 'Comprehensive Cancer Centre The Netherlands', 'class': 'OTHER'}, {'name': 'Dutch Institute for Clinical Auditing (DICA)', 'class': 'UNKNOWN'}, {'name': 'ZorgTTP', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}