Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-23 @ 12:10 AM
Study NCT ID:
NCT04277403
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HA-WBRT vs SRS in Patients With Multiple 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Observer-blinding'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracranial Progression free survival', 'timeFrame': 'up to 18 months', 'description': 'survival with freedom from both local and distant intracranial progression, measured in months from end of treatment until progression or death, assessed in follow-up imaging (MRI, FET-PET)'}], 'secondaryOutcomes': [{'measure': 'Neurocognitive function assessed by VLMT', 'timeFrame': 'up to 18 months', 'description': 'Change of z-scores of VLMT (Verbaler Lern- und Merkfähigkeitstest) to baseline examination'}, {'measure': 'Neurocognitive function assessed by COWAT', 'timeFrame': 'up to 18 months', 'description': 'Change of z-scores of COWAT (controlled oral word association test) to baseline examination'}, {'measure': 'Neurocognitive function assessed by TMT', 'timeFrame': 'up to 18 months', 'description': 'Change of z-scores of TMT (trail making test) to baseline examination'}, {'measure': 'Local control rate', 'timeFrame': 'up to 18 months', 'description': 'rate of progression of treated metastases assessed in follow-up imaging (MRI, FET-PET)'}, {'measure': 'Survival time', 'timeFrame': 'up to 18 months', 'description': 'time from end of treatment to death'}, {'measure': 'Quality of Life Score assessed by EORTC QLQ-C30 questionnaire', 'timeFrame': 'up to 18 months', 'description': 'Change in Quality of Life Score of EORTC QLQ-C30 (Quality of life core module) relative to baseline'}, {'measure': 'Quality of Life Score assessed by QLQ-BN20 questionnaire', 'timeFrame': 'up to 18 months', 'description': 'Change in Quality of Life Score of QLQ-BN20 (quality of life brain cancer module) relative to baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brain metastases', 'hippocampal avoidance', 'radiosurgery'], 'conditions': ['Brain Metastases']}, 'descriptionModule': {'briefSummary': 'This study compares the effectiveness and safety of two radiation treatment techniques for patients with multiple brain metastases.', 'detailedDescription': 'For patients suffering from multiple brain metastases whole brain radiation therapy still constitutes a standard therapy. However, because of the risk of neurocognitive side effects as well as reduced local tumor control, employment of stereotactic radiosurgery (SRS) is becoming more common. The disadvantage of SRS alone may be poor intracranial tumor control because of frequent appearance of new distant brain metastases after therapy. In recent years hippocampal avoidance whole brain therapy has been shown to minimize treatment related side effects while reducing the rate of distant intracranial failure.\n\nIn this study patients will be randomized to receive either hippocampal avoidance whole brain radiation therapy with integrated tumor boost (HA-WBRT+SIB) or stereotactic radiosurgery. The investigators hypothesize that HA-WBRT+SIB can improve intracranial tumor control compared to stereotactic radiosurgery, while avoiding additional neurocognitive side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 4 and not exceeding 15 brain metastases not exceeding a combined total volume of 25ml and not previously treated with radiotherapy\n* KPI ≥ 70, ECOG ≤ 2\n* Age ≥ 18 years, Male or female\n\nExclusion Criteria:\n\n* Neuroendocrine, SCLC, germinoma or lymphoma histology\n* Brain stem metastasis\n* Life expectancy \\< 3 months\n* Suspicion of meningeosis carcinomatosa\n* Previous WBRT\n* Inability to participate in radiologic follow-up, contraindication to MR imaging (e.g. not MRI compatible pacemaker, severe claustrophobia)\n* Inability to participate in neurocognitive function testing, insufficient German language skills, aphasia, graphomotor impairment, insufficient vision, insufficient attention span\n* Pregnancy, nursing or unwillingness to prevent pregnancy using effective methods of contraception during treatment\n* Known abuse of medication, drugs or alcohol\n* Known severe dementia (z-score \\< 2) or major cognitive function disorder that is not caused by intracranial tumour\n* Known clinical depression or psychotic disorder'}, 'identificationModule': {'nctId': 'NCT04277403', 'acronym': 'HipSter', 'briefTitle': 'HA-WBRT vs SRS in Patients With Multiple Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Hippocampal Avoidance Whole Brain Radiotherapy (HA-WBRT) and Stereotactic Radiosurgery (SRS) in Patients With Multiple Brain Metastases', 'orgStudyIdInfo': {'id': 'HIPSTER_2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HA-WBRT+SIB', 'description': 'Hippocampal avoiding Whole brain radiation therapy (HA-WBRT) with volumetric modulated arc therapy (VMAT) with a simultaneously integrated boost (SIB) to each brain metastasis', 'interventionNames': ['Radiation: Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SRS', 'description': 'Single session or hypofractionated stereotactic radiosurgery (SRS) of multiple brain metastases', 'interventionNames': ['Radiation: Single session or hypofractionated stereotactic radiosurgery']}], 'interventions': [{'name': 'Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost', 'type': 'RADIATION', 'description': 'Hippocampal avoiding Whole brain radiation therapy (HA-WBRT) with volumetric modulated arc therapy (VMAT) with a prescribed dose of 30Gy in 12 fractions, 2.5Gy per fraction and a simultaneously integrated boost (SIB) to each brain metastasis of 51Gy to 95% of PTV in 12 Fractions, 4.25Gy per fraction.', 'armGroupLabels': ['HA-WBRT+SIB']}, {'name': 'Single session or hypofractionated stereotactic radiosurgery', 'type': 'RADIATION', 'description': 'Single session or hypofractionated stereotactic radiosurgery (SRS) of multiple brain metastases. Single session SRS will be delivered in 18 to 22Gy to the tumour encompassing 80% Isodose. Hypofractionated stereotactic radiosurgery (HfSRS) will be delivered in 5 sessions of 6Gy each to the tumour encompassing 80% isodose.', 'armGroupLabels': ['SRS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Julian Mangesius, MD', 'role': 'CONTACT', 'email': 'julian.mangesius@i-med.ac.at'}, {'name': 'Ute Maria Ganswindt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Julian Mangesius, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Julian Mangesius, MD', 'role': 'CONTACT', 'email': 'julian.mangesius@i-med.ac.at'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}