[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-neoplasms":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100596016","phase-2-standard-dose-versus-high-dose-stereotactic-spine-radiosurgery-for-metastatic-spinal-neoplasms-100596016",false,"NCT07039968","Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms","Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms - SHINE: A Prospective Randomized Trial","Inclusion Criteria:\n\n1. Patients with a histologic diagnosis of non-hematopoietic malignancy\n2. Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion\n3. Maximum four separate sites with a maximal involvement of two continuous vertebral levels\n4. Patients do not have prior radiotherapy to the index spine(s)\n5. Age ≥ 18 years\n6. Karnofsky performance status (KPS) ≥ 60%.\n7. Life expectancy ≥ 12 months.\n8. Women of childbearing potential and male participants must practice adequate contraception\n9. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent\n\nExclusion Criteria:\n\n1. Prior radiotherapy or radiosurgery to the index spine(s)\n2. Serum creatinine \\> 2.0 mg\u002FdL within 90 days prior registration\n3. Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia\n4. Patients with metastatict epidural spinal cord compression (≥ grade 2) at the index spine(s) indicative of upfront spine surgery\n5. Inability to tolerate treatment procedure\n6. Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:\n\n   1. Uncontrolled active infection requiring intravenous antibiotics at the time of registration\n   2. Transmural myocardial infarction ≤ 6 months prior to registration\n   3. Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration\n   4. Life-threatening uncontrolled clinically significant cardiac arrhythmias\n   5. Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects\n   6. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\n   7. Uncontrolled psychiatric disorder\n7. Will receive any other investigational agent or chemotherapy and\u002For target therapies during treatment\n8. Women of childbearing potential and male participants who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic\n9. Pregnant or breast-feeding women","ALL","18 Years",{"count":19,"type":20},196,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn if a higher dose of Stereotactic Spine Radiosurgery (SSRS), an advanced radiation technique, is better for treating cancer that has spread to the spine (spinal metastases). The study will also learn about the safety of using a higher dose.\n\nThe main questions it aims to answer are:\n\nDoes a higher radiation dose lead to fewer treatment failures (meaning the tumor growing back or causing serious side effects) one year after treatment? What are the side effects associated with the high dose compared to the standard dose? How does each radiation dose affect a patient's pain and quality of life?\n\nResearchers will randomly assign participants (like a coin toss) to one of two groups to compare the outcomes:\n\nThe Standard Dose Group: Will receive a single radiation treatment of 16 Gy. The High Dose Group: Will receive a single, more powerful radiation treatment of 20 Gy.\n\nParticipants in this study will:\n\nReceive a single, one-time, highly-focused radiation treatment (SSRS) to the spinal tumor.\n\nAttend regular follow-up visits at the clinic for checkups and imaging scans (like MRI).\n\nComplete questionnaires about their pain levels and quality of life during these visits.",[26],"Spinal Neoplasms",[28,29],"spine metastasis","stereotactic spine radiosurgery","RECRUITING","2025-06-24",{"date":33,"type":34},"2025-06-26","ACTUAL",{"date":36,"type":20},"2025-06",{"date":38,"type":20},"2035-06",{"name":40,"class":41},"National Taiwan University Hospital","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100563217","separation-surgery-followed-by-stereotactic-ablative-body-radiotherapy-sabr-versus-sabr-alone-for-spinal-metastases-100563217","NCT06613295","Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases","Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy Versus Stereotactic Ablative Body Radiotherapy Alone for Spinal Metastases Invading the Spinal Canal: a Randomised, Non-inferiority Trial","SABR-MESCC","Inclusion Criteria:\n\n* Diagnosis of a solid malignant tumour (preferentially histologically proven;alternatively obtained by spinal surgical procedure)\n* Age 18 years or older\n* Histological, radiological or scintigraphical evidence of spinal metastasis (no limitation in the number of sites of metastases)\n* Spinal instability neoplastic score (SINS) \\\u003C13 (i.e. no need for stabilisation of the spine) (see Appendix 6)\n* Spinal metastasis with MESCC: ESCC grade 1c, 2 and 3 (see Appendix 7)\n* Ambulatory: being able to walk 10m without aid or with aid (cane, rollator, one persons help).\n* Life expectancy estimated to be at least 3 months.\n* World Health Organization (WHO) Performance Status of 0-2 (some help) (see Appendix 3)\n* Patient has given written informed consent.\n\nExclusion Criteria:\n\n* Contra indication for MRI scan (e.g. pacemaker)\n* Previous RT or surgery at the level of the affected vertebrae\n* Non-solid primary tumours (e.g. lymphoma, multiple myeloma, germ cell tumours)\n* Non ambulatory at presentation\n* More than 3 affected vertebrae in one target site\n* More than 2 treatment sites\n* SINS ≥ 13 (unstable spine)",{"count":51,"type":20},128,[53],"NA","This is a non-inferiority, randomised controlled trial to investigate the effect of stereotactic ablative body radiotherapy (SABR) compared to separation surgery followed by SABR in ambulatory patients with malignant epidural spinal cord compression (MESCC).\n\nThe primary objective of the project is investigating the effect of SABR compared to separation surgery followed by SABR in ambulatory patients with MESCC on retaining ambulatory function. The primary endpoint of the study is ambulatory function 3 months post treatment defined as: being able to walk 10m without aid; being able to walk 10m with aid (cane, rollator, one persons help, …); not being able to walk. Secondary outcomes are local control, progression free survival, early and late adverse effects, quality of life, effect on pain and need for reintervention.\n\nThe aim is to randomise 128 patients 1:1 to either \"separation surgery\" followed by SABR (5x 8.0 Gy postoperative) (control arm) vs. SABR alone (5x 8.0 Gy) (study arm).\n\nPatients will be evaluated at 3 and 6 months after treatment with MRI scan, quality of life questionnaires, anamnestic and clinical evaluation at clinical follow ups for assessment of ambulatory function, acute and late toxicity and need for reintervention. Moreover, at 6 weeks, 12 months and 24 months after treatment a teleconsult for assessment of ambulatory function, and need for reintervention will be performed.",[56,26,57],"Solid Tumor","Spinal Tumor","2024-09-23",{"date":60,"type":34},"2024-09-25",{"date":62,"type":34},"2022-03-07",{"date":64,"type":20},"2027-03-01",{"name":66,"class":41},"Cancer Research Antwerp",9]