Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:44 AM
Study NCT ID:
NCT07437820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Due to the difference in the timing of stereotactic radiotherapy treatment (before or after surgery), blinding of patients or investigators will not be possible; however, magnetic resonance imaging will be analyzed by independent centralized review performed by neuroradiologists.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local control rate of the target lesion', 'timeFrame': '6 months', 'description': 'The local control rate of the target lesion will be determined by the percentage of lesions that have recurred locally. Local progression will be defined, for the treated metastatic lesion, by the appearance on follow-up magnetic resonance imaging of contrast enhancement in the surgical cavity, according to the criteria for assessing response in neuro-oncology of brain metastases.'}, {'measure': 'Local control rate of the target lesion', 'timeFrame': '12 months', 'description': 'The local control rate of the target lesion will be determined by the percentage of lesions that have recurred locally. Local progression will be defined, for the treated metastatic lesion, by the appearance on follow-up magnetic resonance imaging of contrast enhancement in the surgical cavity, according to the criteria for assessing response in neuro-oncology of brain metastases.'}, {'measure': 'Local control rate of the target lesion', 'timeFrame': '24 months', 'description': 'The local control rate of the target lesion will be determined by the percentage of lesions that have recurred locally. Local progression will be defined, for the treated metastatic lesion, by the appearance on follow-up magnetic resonance imaging of contrast enhancement in the surgical cavity, according to the criteria for assessing response in neuro-oncology of brain metastases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Metastases, Adult']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the local control rate on the target lesion at 6, 12, and 24 months after treatment with neoadjuvant stereotactic radiotherapy (SRS NEO group) compared to standard care, adjuvant stereotactic radiotherapy (POST OP SRS group).', 'detailedDescription': 'This is a phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study designed to evaluate the efficacy in terms of local progression-free survival of neoadjuvant stereotactic radiotherapy for brain metastases compared with adjuvant stereotactic radiotherapy.\n\nThe study population is composed of adult patients with 1 to 12 newly diagnosed brain metastases who require surgical treatment for the removal of at least one lesion.\n\nThe two therapeutic strategies studied in the trial are as follows:\n\n* SRS NEO group (experimental group): stereotactic radiotherapy administered as neoadjuvant therapy (4 days ± 1 day before surgery to remove the brain metastasis).\n* POST OP SRS group (control group): stereotactic radiotherapy performed adjuvantly (4 to 6 weeks after surgery to remove the brain metastasis).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and older;\n* Patients with 1 to 12 brain metastases on preoperative MRI, at least one of which (contrast enhancement of at least 1 cm) is accessible for the most complete possible resection (target lesion);\n* Patients with a Karnofsky performance score of ≥ 70;\n* Patients able to perform neurocognitive tests without assistance;\n* Patients who understand the study and agree to attend all visits;\n* Patients who have signed a written informed consent form;\n* Affiliation with a social security system.\n\nExclusion Criteria:\n\n* Patient who has already been treated with surgery, radiosurgery, and/or radiotherapy for the target brain metastasis;\n* Medical contraindication to MRI;\n* Patient with an estimated life expectancy of ≤ 3 months;\n* Patients participating in another clinical trial, or who are in the exclusion period of another clinical trial;\n* Patients unable to complete a self-administered questionnaire;\n* Patients from a vulnerable population.'}, 'identificationModule': {'nctId': 'NCT07437820', 'acronym': 'NeoSRS', 'briefTitle': 'Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Prospective, Randomized, Multicenter Study Comparing the Efficacy and Tolerance of Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy in the Management of Brain Metastases', 'orgStudyIdInfo': {'id': '2025-A02642-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant stereotactic radiotherapy', 'description': 'Innovative treatment with neoadjuvant stereotactic radiotherapy, with the protocol requiring SRS to be performed 4 days ± 1 day before surgery to remove the target brain metastasis.\n\nNeuronavigation magnetic resonance imaging and a tracking scan, necessary for contouring the lesions and creating the treatment mask, will be performed within 7 days prior to the start of radiotherapy. These examinations are essential regardless of the type of stereotactic radiotherapy (adjuvant or neoadjuvant) and are routinely performed for lesion contouring.', 'interventionNames': ['Radiation: stereotactic radiotherapy', 'Procedure: Excision surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group : adjuvant stereotactic radiotherapy', 'description': 'Standard care in accordance with the gold standard, with stereotactic radiotherapy performed as an adjunct to the surgical bed of the targeted lesion, i.e., 4 to 6 weeks after surgery. Neuronavigation magnetic resonance imaging and a tracking scan, necessary for contouring the lesions and creating the treatment mask, will be performed within 7 days prior to the start of radiotherapy.', 'interventionNames': ['Radiation: stereotactic radiotherapy', 'Procedure: Excision surgery']}], 'interventions': [{'name': 'stereotactic radiotherapy', 'type': 'RADIATION', 'description': 'Stereotactic radiotherapy is part of the standard treatment for brain metastases.', 'armGroupLabels': ['Control group : adjuvant stereotactic radiotherapy', 'Neoadjuvant stereotactic radiotherapy']}, {'name': 'Excision surgery', 'type': 'PROCEDURE', 'description': 'Brain metastasis removal surgery', 'armGroupLabels': ['Control group : adjuvant stereotactic radiotherapy', 'Neoadjuvant stereotactic radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13273', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Philippe METELLUS, MD', 'role': 'CONTACT', 'email': 'philippe.metellus@outlook.fr', 'phone': '04 91 17 14 83', 'phoneExt': '+33'}], 'facility': 'Hôpital Privé Clairval', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Philippe METELLUS, MD', 'role': 'CONTACT', 'email': 'philippe.metellus@outlook.fr', 'phone': '04 91 17 14 83', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'collaborators': [{'name': 'Euraxi Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}