Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 7:08 AM
Study NCT ID:
NCT05303259
Status:
RECRUITING
Last Update Posted:
2022-03-31
First Post:
2021-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 204}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-20', 'studyFirstSubmitDate': '2021-12-19', 'studyFirstSubmitQcDate': '2022-03-20', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence and duration of onset of clinical symptoms.', 'timeFrame': 'Change form baseline to evaluation at 1 year.', 'description': 'The incidence and duration of onset of clinical symptoms within 1 year after treatment between the treatment group and the control group.'}], 'secondaryOutcomes': [{'measure': 'change of RI volume.', 'timeFrame': 'Change form baseline to evaluation at 1 year.', 'description': 'The change of RI volume between the treatment group and the control group.'}, {'measure': 'change of cognitive function.', 'timeFrame': 'Change form baseline to evaluation at 1 year.', 'description': 'The change of cognitive function (MoCa scores) between the treatment group and the control group. The MoCA score ranges from 0 to 30, and higher scores mean a better outcome.'}, {'measure': 'overall survival', 'timeFrame': 'Change form baseline to evaluation at 1 year.', 'description': 'the overall survival between the treatment group and the control group.'}, {'measure': 'change of quality of life.', 'timeFrame': 'Change form baseline to evaluation at 1 year.', 'description': 'The change of quality of life ( WHOQOL scale) between the treatment group and the control group. The higher the QOL scores mean a better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Injuries']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.', 'detailedDescription': 'Radiotherapy-induced brain injury (RI) is a serious complication of radiotherapy in head and neck cancer (HNC) patients. Previous studies have confirmed that Bevacizumab has a good effect on patients with symptomatic RI .However, patients with RI maybe do not show clinical symptoms in the early stage. The clinical symptoms will appear with the progression of the RI lesion. There has been no relevant research on whether early intervention is necessary for asymptomatic RI. The investigators conduct this multicenter, randomized clinical research to explore the efficacy and safety of Bevacizumab in asymptomatic RI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHead MRI confirmed RI lesions. Sign the informed consent.\n\nExclusion Criteria:\n\nWith clinical symptoms of RI lesions. Head MRI showed bleeding lesions Contraindications of Bevacizumab. Pregnant women and parturient women.'}, 'identificationModule': {'nctId': 'NCT05303259', 'acronym': 'BRAIN', 'briefTitle': 'Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury in Patients With Head and Neck Cancer', 'orgStudyIdInfo': {'id': '2021-KY-095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HNC patients with radiation-induced brain injury.', 'description': 'Bevacizumab 2.5mg/kg， q2w，4 cycles.', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'NO_INTERVENTION', 'label': 'HNC patients without brain injury after radiotherapy.', 'description': 'No treatment.'}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Bevacizumab 2.5mg/kg, q2w, 4 cycles.', 'armGroupLabels': ['HNC patients with radiation-induced brain injury.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yamei Tang, PHD', 'role': 'CONTACT', 'email': 'tangym@mail.sysu.edu.cn', 'phone': '+86 13556001992'}], 'facility': 'Sun Yat-Sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yamei Tang, PHD', 'role': 'CONTACT', 'email': 'tangym@mail.sysu.edu.cn', 'phone': '+86 13556001992'}], 'overallOfficials': [{'name': 'Yamei Tang, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'sun yat-sen memorial hospital,sun yat-sen universicy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}