Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
Study NCT ID:
NCT04358666
Status:
UNKNOWN
Last Update Posted:
2020-04-24
First Post:
2020-03-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomization between surgery and focal radiosurgery of the surgical site and hypofractionned radiosurgery of the tumor'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-22', 'studyFirstSubmitDate': '2020-03-31', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life EORTC QLQ C30', 'timeFrame': 'change between baseline and 6 month', 'description': 'score European Organisation for Research and Treatment of Cancer Quality Life Quotation C30'}], 'secondaryOutcomes': [{'measure': 'local control of the desease', 'timeFrame': 'baseline up to 24 month'}, {'measure': 'survival without progression', 'timeFrame': '24 month'}, {'measure': 'overall survival', 'timeFrame': '24 month'}, {'measure': 'medico economic evaluation', 'timeFrame': '24 month', 'description': 'cost-utility analysis'}, {'measure': 'neuro cognitive evaluation', 'timeFrame': '12 and 24 month', 'description': 'BOSTON NAMING TEST'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery'], 'conditions': ['Quality of Life', 'Brain Metastases']}, 'descriptionModule': {'briefSummary': 'Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion.\n\nsecond objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol', 'detailedDescription': 'A patient with a brain metastasis may have the choice between surgery and focal radiosurgery of the surgical site and only hypofractionned radiosurgery on the lesion.\n\nNo previous study has focused on quality of life regarding these two treatments options.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eligible for both treatments options OMS status \\<3 primary cancer with no evolution brain metastasis \\< 3cm ou giving symtoms patient with informed consent patient affilated to french social security\n\nExclusion Criteria:\n\n* OMS \\> 3 More than 3 brain metastasis brain metastasis already treated with hypofractionned radiosurgery'}, 'identificationModule': {'nctId': 'NCT04358666', 'acronym': 'OPTMETACER', 'briefTitle': 'Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis', 'orgStudyIdInfo': {'id': '19-086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'surgery and focal radiosurgery of the surgical site', 'interventionNames': ['Procedure: surgery and focal radiosurgery of the surgical bed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hypofractionned radiosurgery', 'interventionNames': ['Procedure: surgery and focal radiosurgery of the surgical bed']}], 'interventions': [{'name': 'surgery and focal radiosurgery of the surgical bed', 'type': 'PROCEDURE', 'otherNames': ['hypofractionned radiosurgery of the lesion'], 'description': 'hypofractionned radiosurgery of the lesion', 'armGroupLabels': ['hypofractionned radiosurgery', 'surgery and focal radiosurgery of the surgical site']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Evelyne Emery, MD PhD', 'role': 'CONTACT', 'email': 'emery-e@chu-caen.fr', 'phone': '+33 2064605'}, {'name': 'jean jacques Dutheil, PhD', 'role': 'CONTACT', 'email': 'dutheil-jj@chu-caen.fr', 'phone': '+33 231065351'}], 'facility': 'CHU CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}