Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 6:00 PM
Study NCT ID:
NCT05588206
Status:
UNKNOWN
Last Update Posted:
2022-10-20
First Post:
2022-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD', 'timeFrame': '1 years', 'description': 'maximum tolerated dose'}], 'secondaryOutcomes': [{'measure': 'ARE', 'timeFrame': '2 years', 'description': 'adverse radiation effect'}, {'measure': 'iPFS', 'timeFrame': '2 years', 'description': 'intracranial progression-free survival defines as intervals from treatment to intracranial disease progression or death'}, {'measure': 'OS', 'timeFrame': '2 years', 'description': 'overall survival (OS) intervals from treatment to death or last follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'Brain Metastases', 'Hypofractionated Stereotactic Radiotherapy'], 'conditions': ['Non Small Cell Lung Cancer', 'Stage IV Non-small Cell Lung Cancer', 'Brain Metastases']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.', 'detailedDescription': 'The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histology confirmed that it was non-small cell lung cancer\n* 1 to 10 brain metastases detected by magnetic resonance imaging (MRI)\n* A life expectancy of \\>3 months according to the DS GPA.\n* KPS ≥70\n* Control of the primary lesions (thorax) at the time of SBRT\n* 2cm\\<Tumor size ≤ 4 cm\n* Age of 18-75 years old\n* Patients must be able to undergo contrast enhanced MRI for planning\n* Adequate bone marrow and organ function\n\nExclusion Criteria:\n\n* other malignant tumors\n* Prior surgery to brain metastasis\n* Prior brain radiotherapy\n* Non-small cell lung cancer with more than 10 brain metastases detected by MRI\n* Contraindication to receiving radiotherapy.'}, 'identificationModule': {'nctId': 'NCT05588206', 'briefTitle': 'Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'Dose-escalation by Hypofractionated Stereotactic Radiotherapy Simultaneous Integrated Boost IMRT for Brain Metastases in Non Small Cell Lung Cancer：A Phase I Study', 'orgStudyIdInfo': {'id': 'DeHSRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated Stereotactic Radiotherapy for Brain Metastases', 'interventionNames': ['Radiation: Hypofractionated Stereotactic Radiotherap']}], 'interventions': [{'name': 'Hypofractionated Stereotactic Radiotherap', 'type': 'RADIATION', 'description': 'A standard 3+3 statistical design was employed. Three patients will initially be treated at dose level 1, 6 Gy in 5 fractions, 3 fractions a week. Dose limiting toxicities (DLT) were defined as any grade 3-5 radiation injury or any non-hematologic toxicity felt to be possibly, probably, or definitely related to radiation, identified within the evaluation period of 3 months following the completion of radiotherapy.', 'armGroupLabels': ['Hypofractionated Stereotactic Radiotherapy for Brain Metastases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kaicheng Pan', 'role': 'CONTACT', 'email': '15732192994@163.com', 'phone': '057156006382'}], 'facility': 'Kaicheng Pan', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Bing Xia', 'role': 'CONTACT', 'email': 'bingxia_hzch@163.com', 'phone': '057156006382'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hangzhou Cancer Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}