Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-03-13 @ 5:39 PM
Study NCT ID:
NCT02104193
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2014-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simvastatin Effect on Radiation Therapy 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2014-04-01', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'quality of life', 'timeFrame': 'baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks', 'description': 'measures the patient quality of life'}, {'measure': 'cognitive function assessment using Montreal cognitive assessment test', 'timeFrame': 'baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks', 'description': 'assess the patient cognitive function by the evaluation of Montreal cognitive assessment test score'}, {'measure': 'serum s100 B protein', 'timeFrame': 'baseline, after radiation therapy', 'description': 'evaluate serum s100 B protein at baseline and after 2 weeks'}], 'primaryOutcomes': [{'measure': 'a- Response rate', 'timeFrame': '4 weeks after radiation therapy', 'description': 'brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size'}], 'secondaryOutcomes': [{'measure': 'progression free and overall survival', 'timeFrame': 'up to 6 months', 'description': 'it measures time from treatment initiation to either progression or death from any cause'}, {'measure': 'adverse effects', 'timeFrame': 'during the treatment period', 'description': 'any adverse/side effect will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['brain metastases', 'simvastatin', 'radiation therapy'], 'conditions': ['Brain Metastases']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effect of simvastatin in combination with radiotherapy on the clinical outcomes of patients with brain metastases.', 'detailedDescription': "Despite current advances in therapies, the outcome for patients with brain metastases is fatal. New therapeutic approaches, such as radiosensitizing agents, are needed to provide a significant survival advantage for those patients. Statins have been reported to enhance the efficacy of radiotherapy in addition to a neuroprotective effect. The aim of the study is to evaluate the effect of simvastatin on the efficacy and safety of radiation therapy in patients with brain metastases and on improving patients' quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with measurable brain metastases\n* Age more than 18 years old\n* Patients should be planned for radiation therapy\n\nExclusion Criteria:\n\n* Renal dysfunction (more than 1 upper normal level)\n* Hepatic dysfunction (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\>3 times the upper normal level )\n* Pregnancy or lactation.\n* Known hypersensitivity to simvastatin'}, 'identificationModule': {'nctId': 'NCT02104193', 'briefTitle': 'Simvastatin Effect on Radiation Therapy of Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Effect of Simvastatin on the Clinical Outcome of Patients With Brain Metastases Treated With Radiation Therapy: a Pilot Study', 'orgStudyIdInfo': {'id': 'PH CL 25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'simvastatin', 'description': 'they will receive simvastatin in addition to radiation therapy', 'interventionNames': ['Drug: simvastatin in addition to radiation therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'they will receive radiation therapy only', 'interventionNames': ['Radiation: radiation therapy']}], 'interventions': [{'name': 'simvastatin in addition to radiation therapy', 'type': 'DRUG', 'description': 'simvastatin 80 mg tablet once daily during the radiation therapy period in addition to radiation therapy 30 Gy delivered in 10 fractions over 2 weeks', 'armGroupLabels': ['simvastatin']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'radiation therapy 30 Gy delivered in 10 fractions over 2 weeks', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams university Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'May A Shawki, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Pharmacy- Ain Shams university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'teaching assisstant', 'investigatorFullName': 'MAy Ahmed Shawki', 'investigatorAffiliation': 'Ain Shams University'}}}}