Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT03392233
Status:
RECRUITING
Last Update Posted:
2018-01-05
First Post:
2017-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-01', 'studyFirstSubmitDate': '2017-12-31', 'studyFirstSubmitQcDate': '2018-01-01', 'lastUpdatePostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of relieve pain', 'timeFrame': 'One week after radiation to 2 years late', 'description': 'According to the Numerical Rating Pain Scale (NRPS)'}], 'secondaryOutcomes': [{'measure': 'The degree of relieve pain', 'timeFrame': 'One week after radiation to 2 years late', 'description': 'According to the Numerical Rating Pain Scale (NRPS)'}, {'measure': 'The duration relieve pain', 'timeFrame': 'One week after radiation to 2 years late', 'description': 'According to the Numerical Rating Pain Scale (NRPS)'}, {'measure': 'The incidence of toxicity', 'timeFrame': 'One week after radiation to 2 years late', 'description': 'Common Terminology Criteria for Adverse Events v3.0 (CTCAE)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal metastases', 'Stereotactic body radiation therapy(SBRT)', 'breast cancer', 'prostate cancer', 'non small cell lung cancer'], 'conditions': ['Breast Cancer', 'Prostate Cancer', 'Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Stereotactic Body Radiation Therapy(SBRT) for spinal metastases has been proved a good results in pain relieve and local control, However,the longterm of efficacy and safety of this regimen is unclear.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years.', 'detailedDescription': "Recently,Stereotactic Body Radiation Therapy(SBRT) become an alternative regimen for spinal metastases due to it's high dose cover the metastatic lesion and low dose in the adjacent spinal cord which result in more efficacy and less toxicity. However,the longterm of efficacy and safety of this regimen is unclear because of shortly median survival among unselective spinal metastases.To our knowledge,the median survival of some favorite metastatic diseases will be more than two years if they received appropriate system therapy.these include hormones dependent brest cancer/prostate cancer,and EGFR mutation non-small cell lung cancer(NSCLC) ect.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. WHO scores 0-2;\n2. The primary lesion was confirmed by pathology or cytology;\n3. The metastatic lesions were diagnosed by imaging(CT,MRI,PET-CT,ECT),or the lesions were confirmed by biopsy;\n4. The metastatic lesion was limited in 3 consecutive vertebral bodies;\n5. The baseline pain score was ≥5(NRPS) and the use of analgesic drugs was recorded;\n6. The enhanced MRI scan of involved vertebral bodies was required in the 2 weeks before radiotherapy;\n\nAdequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:\n\n1. Leukocytes ≥ 3.0 x109/ L;\n2. Absolute neutrophil count (ANC) ≥ 1.5 x109/ L;\n3. Platelet count ≥ 100 x109/ L;\n4. Hemoglobin (Hb) ≥ 9g/ dL;\n5. Total bilirubin ≤1.5 x the upper limit of normal (ULN);\n6. Alanine aminotransferase (ALT) ≤ 3 x ULN;\n7. Aspartate aminotransferase (AST) ≤ 3 x ULN;\n8. Serum creatinine ≤ 1.5 x the ULN;\n9. Signed informed consent;\n\nExclusion Criteria:\n\n1. There were significant changes in the shape of the vertebral body (the height of the vertebral body was compressed≥ 50%) or the vertebral body was unchanged but the volume of the dissolving bone was≥ 50% and could lead to serious bone adverse events;\n2. There were \\>3 consecutive vertebral bodies involved;\n3. Spinal cord compression has occurred;\n4. The gap between tumor and spinal cord was less than 3mm;\n5. The metastatic area previously received radiation;\n6. Pregnant and Nursing women;\n7. Uncontrolled co-morbid illnesses;\n\n9.refused to signed informed consent;'}, 'identificationModule': {'nctId': 'NCT03392233', 'briefTitle': 'Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Phase II Study to Evaluated the Long-term of Safety and Efficacy of Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors', 'orgStudyIdInfo': {'id': 'SBRT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase II open lable Study', 'description': 'Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time.', 'interventionNames': ['Radiation: Stereotactic Body Radiation Therapy']}], 'interventions': [{'name': 'Stereotactic Body Radiation Therapy', 'type': 'RADIATION', 'description': 'Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time', 'armGroupLabels': ['Phase II open lable Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Ye, Master', 'role': 'CONTACT', 'email': 'renjiyeming@163.com', 'phone': '+862168383459'}, {'name': 'Qi Lu, Master', 'role': 'CONTACT', 'email': 'luqi@renji.com', 'phone': '+862158752345', 'phoneExt': '33364'}, {'name': 'Ming Ye, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ming Ye, Master', 'role': 'CONTACT', 'email': 'renjiyeming@163.com', 'phone': '+862168383459'}, {'name': 'Qi Lu, Master', 'role': 'CONTACT', 'email': 'luqi@renji.com', 'phone': '+8621-58752345', 'phoneExt': '33364'}], 'overallOfficials': [{'name': 'Ming Ye, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}