Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-31 @ 8:59 PM
Study NCT ID:
NCT03818503
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2019-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients treated with radiotherapy enrolled in the program', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '5 years'}, {'measure': 'Loco-regional control', 'timeFrame': '5 years'}, {'measure': 'Distant metastasis free survival', 'timeFrame': '5 years'}, {'measure': 'Overall survival', 'timeFrame': '5 years'}, {'measure': 'Incidence of adverse events related to radiotherapy', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '38508239', 'type': 'DERIVED', 'citation': 'Christ SM, Alongi F, Ricardi U, Scorsetti M, Livi L, Balermpas P, Lievens Y, Braam P, Jereczek-Fossa BA, Stellamans K, Ratosa I, Widder J, Peulen H, Dirix P, Bral S, Ramella S, Hemmatazad H, Khanfir K, Geets X, Jeene P, Zilli T, Fournier B, Ivaldi GB, Clementel E, Fortpied C, Oppong FB, Ost P, Guckenberger M. Cancer-specific dose and fractionation schedules in stereotactic body radiotherapy for oligometastatic disease: An interim analysis of the EORTC-ESTRO E2-RADIatE OligoCare study. Radiother Oncol. 2024 Jun;195:110235. doi: 10.1016/j.radonc.2024.110235. Epub 2024 Mar 19.'}, {'pmid': '37500926', 'type': 'DERIVED', 'citation': 'Nieder C, Willmann J, Andratschke NH. Prospective randomized clinical studies involving reirradiation: update of a systematic review. Strahlenther Onkol. 2023 Sep;199(9):787-797. doi: 10.1007/s00066-023-02118-1. Epub 2023 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is the collection of real-world data of cancer patients treated with radiotherapy, to support radiotherapy research and to provide evidence of the role of radiation oncology in a multidisciplinary approach. This is an open ended prospective non-interventional non-therapeutic multi-cohort study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with various tumor types planned to be treated with radiation therapy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed cancer.\n* Written informed consent for E²-RADIatE according to applicable legal and ethical requirements\n* Planned use of radiotherapy\n* Eligibility of the patient confirmed for at least one cohort confirmed\n* Patients of 12 years and older'}, 'identificationModule': {'nctId': 'NCT03818503', 'acronym': 'E²-RADIatE', 'briefTitle': 'E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe', 'orgStudyIdInfo': {'id': 'EORTC-1811'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OligoCare', 'description': 'Patients with oligometastatic disease treated with radical radiotherapy'}, {'label': 'ReCare', 'description': 'Patients treated with high-dose Re-irradiation'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AT 8036', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Medical University of Graz - Radio-oncology', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'AT 4010', 'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Ordensklinikum Linz-Barmherzige Schwestern', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': 'AT 1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH unikliniken', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '9300', 'city': 'Aalst', 'status': 'SUSPENDED', 'country': 'Belgium', 'facility': 'Onze Lieve Vrouw Ziekenhuis', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'BE 1070', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'BE 9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'AZ Sint-Lucas & Volkskliniek', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '8500', 'city': 'Kortrijk', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'AZ Groeninge Kortrijk - Campus Kennedylaan', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': 'BE 3000', 'city': 'Leuven', 'status': 'SUSPENDED', 'country': 'Belgium', 'facility': 'U.Z. 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EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}