Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT05346367
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for 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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-14', 'size': 1085191, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-28T10:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'radio necrosis or local failure', 'timeFrame': '2 years after treatment', 'description': 'Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '2 years after treatment', 'description': 'median survival with Kaplan Meyer analysis'}, {'measure': 'symptomatic radio necrosis (RN) or local failure (LF)', 'timeFrame': '2 years after treatment', 'description': 'incidence of RN or LF within 2 years after SRT'}, {'measure': 'salvage treatment', 'timeFrame': '2 years after treatment', 'description': 'incidence of salvage treatment within 2 years after SRT'}, {'measure': 'distant brain recurrences', 'timeFrame': '2 years after treatment', 'description': 'incidence of distant brain recurrences within 2 years after SRT'}, {'measure': 'Dose dexamethasone', 'timeFrame': 'baseline - 2 years after treatment', 'description': 'Dose dexamethasone in mg per day'}, {'measure': 'Anti-epileptic drug use', 'timeFrame': 'baseline - 2 years after treatment', 'description': 'Anti-epileptic drug use in mg per day'}, {'measure': 'Grade 2 or more toxicity (CTCAE v5.0)', 'timeFrame': 'baseline - 2 years after treatment', 'description': 'incidence of Grade 2 or more toxicity according to CTCAE version 5.0 within 2 years after SRT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fractionated stereotactic radiotherapy'], 'conditions': ['Brain Metastases']}, 'referencesModule': {'references': [{'pmid': '36964529', 'type': 'DERIVED', 'citation': 'Crouzen JA, Petoukhova AL, Broekman MLD, Fiocco M, Fisscher UJ, Franssen JH, Gadellaa-van Hooijdonk CGM, Kerkhof M, Kiderlen M, Mast ME, van Rij CM, Nandoe Tewarie R, van de Sande MAE, van der Toorn PPG, Vlasman R, Vos MJ, van der Voort van Zyp NCMG, Wiggenraad RGJ, Wiltink LM, Zindler JD. SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic radiosurgery for brain metastases. BMC Cancer. 2023 Mar 25;23(1):273. doi: 10.1186/s12885-023-10761-1.'}]}, 'descriptionModule': {'briefSummary': 'Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.', 'detailedDescription': 'Randomized phase II trial. Stereotactic radiotherapy is one of the most frequently chosen treatment options for brain metastases. There are an increasing number of long term survivors. Brain necrosis (e.g. radio necrosis) is the most important long term side effect of the treatment, occurring in up to 40% of patients, dependent on the size of the metastasis and delivered radiotherapy dose. Retrospective studies have shown that the incidence of radio necrosis, as well as local tumor recurrence, can be decreased with a risk difference of around 20% by administrating fractionated stereotactic radiotherapy (fSRT, e.g. five fractions) over single fraction stereotactic radiotherapy, especially in large brain metastases. In this trial, one group is treated with SRT in one or three fractions. The other group is treated with fSRT in five fractions. Survival, toxicity and patient reported quality of life are monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* At least one brain metastasis of large cell cancer suitable for SRT\n* Karnofsky Performance Status ≥ 70\n* Ability to provide written informed consent\n* New brain metastases during follow-up after surgery allowed (when outside of resection cavity area)\n* New brain metastases during follow-up after previous SRT allowed (when outside of previous irradiation field)\n\nExclusion Criteria:\n\n* Contra-indication for MRI scan\n* Primary tumor of small cell lung cancer, germinoma or lymphoma\n* Prior whole brain radiotherapy or SRT on the current target brain metastases (in field re-irradiation)\n* Presence of leptomeningeal metastases\n* Previous inclusion in the SAFESTEREO study'}, 'identificationModule': {'nctId': 'NCT05346367', 'acronym': 'SAFESTEREO', 'briefTitle': 'Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Haaglanden Medical Centre'}, 'officialTitle': 'Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases', 'orgStudyIdInfo': {'id': '2021-115LR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SRT (stereotactic radiotherapy)', 'description': 'stereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy', 'interventionNames': ['Radiation: SRT']}, {'type': 'EXPERIMENTAL', 'label': 'fSRT (hypo fractionated stereotactic radiotherapy)', 'description': 'hypo fractionated stereotactic radiotherapy in 5 fractions of 7 Gy up to 35 Gy. Brain stem metastases 5 fractions of 6 Gy up to 30 Gy', 'interventionNames': ['Radiation: fSRT']}], 'interventions': [{'name': 'SRT', 'type': 'RADIATION', 'description': 'SRT', 'armGroupLabels': ['SRT (stereotactic radiotherapy)']}, {'name': 'fSRT', 'type': 'RADIATION', 'description': 'fSRT', 'armGroupLabels': ['fSRT (hypo fractionated stereotactic radiotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2262 BA', 'city': 'Leidschendam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jaap Zindler, Dr', 'role': 'CONTACT', 'email': 'j.zindler@haaglandenmc.nl'}, {'name': 'Ursula Fisscher, PhD', 'role': 'CONTACT', 'email': 'u.fisscher@haaglandenmc.nl'}], 'facility': 'Haaglanden Medisch Centrum', 'geoPoint': {'lat': 52.08167, 'lon': 4.39281}}], 'centralContacts': [{'name': 'Jaap D Zindler, MD, PhD', 'role': 'CONTACT', 'email': 'j.zindler@haaglandenmc.nl', 'phone': '+31-88-9792013'}, {'name': 'Mirjam Mast, PhD', 'role': 'CONTACT', 'email': 'm.mast@haaglandenmc.nl', 'phone': '+31-88-9792013'}], 'overallOfficials': [{'name': 'Jaap D Zindler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haaglanden MC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haaglanden Medical Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD, PhD, radiation oncologist', 'investigatorFullName': 'Jaap Zindler', 'investigatorAffiliation': 'Haaglanden Medical Centre'}}}}