Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-25 @ 5:07 PM
Study NCT ID:
NCT05084092
Status:
UNKNOWN
Last Update Posted:
2022-08-04
First Post:
2021-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IORT After Surgical Resection of Brain Metastases
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intraoperative Radiation Therapy (IORT)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2021-04-08', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median local progression free survival (PFS)', 'timeFrame': '12 months', 'description': 'Time span (in months) between surgery and recurrence within a 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.'}], 'secondaryOutcomes': [{'measure': 'Median regional PFS (rPFS)', 'timeFrame': '12 months', 'description': 'The time (in months) from surgery to any progression outside of the 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.'}, {'measure': 'Global PFS (gPFS)', 'timeFrame': '12 months', 'description': 'Time (in months) from surgery to any intra- and extracranial tumor progression evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.'}, {'measure': 'Median time to the initiation of systemic therapies', 'timeFrame': '12 months', 'description': 'Time (in days) from surgery to the day of initiation of any systemic anti-tumor therapy (e.g., chemotherapy)'}, {'measure': 'Median overall survival (OS)', 'timeFrame': '12 months', 'description': 'Time (in months) from surgery of brain metastases to death by any cause'}, {'measure': 'Change in neurocognitive performance (compared to baseline): Minimental', 'timeFrame': '6, and 12 months', 'description': 'Assessed by minimal mental scale examination'}, {'measure': 'Change in neurocognitive performance (compared to baseline): Trail making', 'timeFrame': '6, and 12 months', 'description': 'Assessed by trail making test'}, {'measure': 'Change in neurocognitive performance (compared to baseline): Repetition', 'timeFrame': '6, and 12 months', 'description': 'Assessed by number repetition test (forward and backward)'}, {'measure': 'Change in neurocognitive performance (compared to baseline): Oral', 'timeFrame': '6, and 12 months', 'description': 'Assessed by controlled oral word association test'}, {'measure': 'Change in neurocognitive performance (compared to baseline): Semantic', 'timeFrame': '6, and 12 months', 'description': 'Assessed by semantic word association'}, {'measure': 'Quality of life (QoL)', 'timeFrame': '6, and 12 months', 'description': 'Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)'}, {'measure': 'Radiation-related (acute / early delayed / late) neurotoxicity', 'timeFrame': '12 months', 'description': 'Assessed by regular neurological examinations combined by serial MRI scans'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain metastases', 'neurosurgery', 'intraoperative radiotherapy', 'local therapy'], 'conditions': ['Brain Neoplasms']}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years, Karnofsky Performance Index ≥ 70.\n* Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1- weighted MRI scan) amenable to total resection with no dural attachment.\n* Frozen section confirming a metastasis of an extracranial (i.e. non-CNS) tumor.\n* Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy).\n* Adequate birth control.\n* Informed consent.\n\nExclusion Criteria:\n\n* Leptomeningeal spread and dural attachment (assessed pre- and intraoperative).\n* Frozen section reveals primary CNS tumor, lymphoma, SCLC or germinoma.\n* Psychiatric or social condition potentially interfering with compliance.\n* Contraindication against anesthesia, surgery, MRI and/or contrast agents.\n* Pregnant or breast-feeding women.'}, 'identificationModule': {'nctId': 'NCT05084092', 'acronym': 'IORT_BRAINM1', 'briefTitle': 'IORT After Surgical Resection of Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': "Institut Català d'Oncologia"}, 'officialTitle': 'IORT After Surgical Resection of Brain Metastases: Feasibility and Efficacy Phase II Trial', 'orgStudyIdInfo': {'id': 'IORT_BRAIN_MET_2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraoperative Radiotherapy (IORT)', 'description': 'Intraoperative Radiotherapy (IORT) administered during surgery', 'interventionNames': ['Radiation: Intraoperative Radiotherapy (IORT)', 'Procedure: Brain surgery']}], 'interventions': [{'name': 'Intraoperative Radiotherapy (IORT)', 'type': 'RADIATION', 'description': 'If biopsy is positive, local treatment with IORT will be performed. After IORT (15,40 Gray at 2 mm dept), the applicator will be removed and surgery will be continued in a standard fashion.', 'armGroupLabels': ['Intraoperative Radiotherapy (IORT)']}, {'name': 'Brain surgery', 'type': 'PROCEDURE', 'description': 'Surgery should be performed according to the local standard of care, preferentially as image-(neuronavigation) guided surgery. To establish the diagnosis of a metastasis and to exclude primary CNS tumors, lymphomas, SCLCs or germinomas it will be performed a peroperative biopsy', 'armGroupLabels': ['Intraoperative Radiotherapy (IORT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08908', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Miquel Macià, MD', 'role': 'CONTACT', 'email': 'mmacia@iconcologia.net', 'phone': '+34 93 260 77 20'}, {'name': 'Anna Lucas, MD', 'role': 'CONTACT', 'email': 'alucas@iconcologia.net', 'phone': '+34 93 260 77 20'}], 'facility': 'Catalan Institute of Oncology', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'centralContacts': [{'name': 'Miquel Macià, MD', 'role': 'CONTACT', 'email': 'mmacia@iconcologia.net', 'phone': '+34 93 260 77 20'}], 'overallOfficials': [{'name': 'Miquel Macià, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut Català d'Oncologia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Català d'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}