[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spine-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spine-metastases":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,79,105,133,156,180,204,246,273,296],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100379287","phase-2-single--vs-two-fraction-spine-stereotactic-radiosurgery-for-the-treatment-of-vertebral-metastases-100379287",false,"NCT04218617","Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases","Inclusion Criteria:\n\n* Karnofsky Performance Status (KPS) ≥ 70\n* RPA class 1 (KPS \\>70 AND controlled systemic disease) or RPA Class 2 (KPS \\>70, uncontrolled systemic disease OR KPS ≤70, age ≥54, no visceral metastases)44 (see Appendix II)\n* Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI.\n* Vertebral metastases must be (1) solitary, (2) at two contiguous levels, or (3) a maximum of three separate sites, with a maximum of two contiguous levels.\n* Radioresistant metastases are permitted (including sarcomas, melanomas, and renal cell carcinomas).\n* Patients with epidural disease are permitted so long as there is no cord compression.\n* Paraspinal extension is permitted, so long as the paraspinal component is ≤5 cm\n* Multiple small metastatic lesions (\\\u003C20% vertebral body involvement) of no clinical correlate are permitted, and not included in the irradiated segments as per RTOG 0631\n* History and physical within four weeks of registration.\n* Negative pregnancy test within four weeks of registration for women of childbearing potential.\n* Diagnostic spine MRI with and without contrast within four weeks of registration\n* Neurological exam within four weeks of registration to rule out rapid neurological decline. Mild to moderate neurological deficits are acceptable, as long as distance between lesion and spinal cord is ≥3 mm\n* Patients may have prior EBRT at the index site.\n* Informed consent of the participant.\n\nExclusion Criteria:\n\n* Lesions at C1-2 or S1-Coccyx.\n* Hematologic malignancies including lymphoma and myeloma.\n* Multiple primary cancers.\n* Primary neoplasms of the spine\n* Prior corpectomy, kyphoplasty\u002Fvertebroplasty, or instrumentation at the site of planned sSRS.\n* Spinal cord compression.\n* Paraspinal mass \\>5 cm.\n* Patients with rapid neurologic decline.\n* Bony retropulsion resulting in neurologic deficit.\n* Patients with contraindications to MRI.\n* Patients allergic to intravenous contrast for MRI or CT.\n* Patients with emergent spinal cord compression.\n* Patients with mechanical instability of the spine.\n* Patients with active connective tissue disease.\n* Patients who previously underwent sSRS to the vertebrae of interest.\n* Patients with diffuse or multilevel metastatic spinal disease with \\>20% involvement of vertebral bodies, defined as involvement of \\>5 vertebral levels.\n* Inability to participate in study activities due to physical or mental limitations.\n* Inability or unwillingness to return for all required follow-up visits and imaging.\n* Inability to deliver sSRS, either 18 Gy in one fraction, or 24 Gy in two fractions.","ALL","18 Years",{"count":18,"type":19},130,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and\u002For neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue.\n\nOne of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and\u002For bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.",[25,26],"Spine Metastases","Spine Stereotactic Radiosurgery (sSRS)",[28,29,30,31],"C79.40","C79.49","C79.51","C79.52","RECRUITING","2026-06-04",{"date":35,"type":36},"2026-06-05","ACTUAL",{"date":38,"type":36},"2020-02-07",{"date":40,"type":19},"2026-10",{"name":42,"class":43},"Case Comprehensive Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":44},"100441087","laser-interstitial-thermal-ablation-and-stereotactic-radiosurgery-for-patients-with-spine-metastases-100441087","NCT05023772","Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases","A Clinical Trial Evaluating the Efficacy of Combining Laser Interstitial Thermal Ablation With and Without Spine Stereotactic Radiosurgery for Patients With Spine Metastases","Inclusion Criteria:\n\n* Age \\> 18 years old. (The indication for this technique is controversial in skeletally immature patients.)\n* Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see Exclusion Criteria), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors.\n* Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by MRI, with and without contrast sequences. Axial T2 sequence is encouraged but not required.\n* The vertebral body site to be treated must be located from T2 to L1\n* No more than 3 contiguous or dis-contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.\n* Motor strength ≥4 out of 5 in extremity or extremities affected by the level of the spinal cord compression (see section 4 for grading method).\n* ECOG performance status \\\u003C2 or Karnofsky performance status (KPS) \\>50\n* Life expectancy \\>3 months.\n* Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Requires open spinal procedure or a percutaneous procedure without the use of image guidance.\n* Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors), as conventional radiation is likely to be effective in such cases.\n* Unable to tolerate general anesthesia and prone position.\n* Unable to undergo MRI scan of the spine.\n* Inability to lie flat on a treatment table for \\>60 minutes.\n* Pregnant. (Urine testing must be done no more than 10 days prior to surgery.)\n* Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months.\n* Frank cord compression or cord compression from bone components or configuration and acute neurological deficits (defined as motor strength \\\u003C4\u002F5 in extremity or extremities affected by the level of the spinal cord compression)",{"count":53,"type":19},60,[55],"NA","The purpose of this research is to combine two complementary modes of treatment, spinal interstitial laser ablation and stereotactic spine radiosurgery (SSRS) for the treatment for spinal tumors near the spinal cord with an objective to improve tumor control, improve pain control, preserve function, and improve quality of life. We will also assess how effective these combined modes of treatment are in patients with spinal metastasis with an epidural component.",[58,59,60,61,25],"Neoplasm Metastasis","Spinal Cord Diseases","Spinal Cord Compression","Spinal Cord Tumor",[63,64,65,66,67,68,69],"Laser Ablation","Spinal Cord","Minimally Invasive Surgical Procedure","Stereotactic Radiosurgery","Pain Control","Metastasis","Epidural Tumor","2026-06-02",{"date":72,"type":36},"2026-06-03",{"date":74,"type":36},"2021-09-02",{"date":76,"type":19},"2028-06-20",{"name":78,"class":43},"Henry Ford Health System",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":44},"100571134","effectiveness-of-radiofrequency-ablation-and-stabilization-in-metastatic-spine-lesions-by-positron-emission-computed-tomography-pet-ct-confirmation-100571134","NCT06716294","Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By Positron Emission Computed Tomography (PET-CT) Confirmation","Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET-CT Confirmation","ABLASPINE","Inclusion Criteria:\n\n* only patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled.\n* lesions to be treated must be metabolically active on PET-CT performed during the last month.\n* Patients will be informed and sould sign an inform consent.\n* post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.\n\nExclusion Criteria:\n\n\\-","90 Years",{"count":89,"type":19},16,"OBSERVATIONAL","This pilot study will try to demonstrate metabolic changes in spine lesions treated by Augmentation and Ablation, according to existing standards of practice. Our purpose is to show the efficacy of a new radiofrequency ablation (RFA) in combination with augmentation, using a percutaneous ablation device (Osteocool-Medtronic) in the treatment of secondary vertebral bone tumor, avoiding concurrent bias related to other treatments of the disease.",[93,94,25,95],"Bone Cancer Metastatic","Radiofrequency Ablation","Vertebral Metastasis","2026-04-06",{"date":98,"type":36},"2026-04-09",{"date":100,"type":36},"2023-01-01",{"date":102,"type":19},"2028-12-31",{"name":104,"class":43},"National and Kapodistrian University of Athens",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":20,"phases":115,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":44},"100480310","phase-1-prophylactic-radiotherapy-of-minimally-symptomatic-spinal-disease-100480310","NCT05534321","Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease","Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD Trial)","PROMISSeD","Inclusion Criteria:\n\n1. Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.\n2. Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:\n\n   1. Bulkiest sites of spinal osseous disease ≥ 2cm,\n   2. Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1)\n   3. Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.\n   4. Vertebral body compression deformity \\> 50%.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.\n4. Age ≥ 18 years.\n5. Able to provide informed consent.\n6. Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.\n\nExclusion Criteria:\n\n1. Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.\n2. Serious medical co-morbidities precluding RT.\n3. Pregnant or lactating women.\n4. Target lesion(s) is\u002Fare complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.\n5. Leptomeningeal disease.\n6. Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.",{"count":114,"type":19},74,[116,22],"PHASE1","Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. While multiple randomized studies have evaluated the efficacy of different RT regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront RT for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (SREs). Since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront RT to reduce the risks of SREs and their sequelae, including hospitalizations.",[25],[120,121,122,123],"Radiotherapy (RT)","Palliative radiotherapy","High-risk asymptomatic spine metastases","Minimal asymptomatic spine metastases","2026-02-13",{"date":126,"type":36},"2026-02-17",{"date":128,"type":36},"2022-08-29",{"date":130,"type":19},"2027-09",{"name":132,"class":43},"Baptist Health South Florida",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100610277","spine-oncology-registry-100610277","NCT07225491","Spine Oncology Registry","A Prospective Registry of Patients Undergoing Surgical Decompression Followed by Radiation Therapy for Spine Tumors","Inclusion Criteria:\n\n* Diagnosis of primary or metastatic disease to the spine who undergo surgical decompression and stabilization followed by radiation therapy\n\nExclusion Criteria:\n\n* Inability to obtain a standard MRI or CT \u002F CT myelogram for radiation treatment planning and dosimetry\n* Inability to receive radiation treatment.\n* Patients under 18 years of age",{"count":141,"type":19},3000,"This is an observational study to evaluate hardware related and oncologic outcomes in adult patients with primary and metastatic spine disease undergoing separation surgery followed by radiation treatment.",[144,25,145],"Spine Tumor","Spine Cancer","2025-12-14",{"date":148,"type":36},"2025-12-19",{"date":150,"type":36},"2025-11-24",{"date":152,"type":19},"2037-12-31",{"name":154,"class":43},"Ohio State University Comprehensive Cancer Center",3,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":20,"phases":164,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":178,"locationsCount":44},"100599871","radiofrequency-ablationbone-augmentation--radiotherapy-vs-radiotherapy-alone-100599871","NCT07090122","Radiofrequency Ablation\u002FBone Augmentation + Radiotherapy vs Radiotherapy Alone","Inclusion Criteria:\n\n* Histologically confirmed metastatic T5-L5 disease of the spine (with up to two levels) as detected by any imaging study.\n* Have either associated bone pain or cross-sectional imaging characteristics that are predictors of SRE.\n* Age 18 years of age or older at the time of consent.\n* Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to study enrollment defined as:\n\n  1. absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n  2. platelets ≥ 50 × 109\u002FL\n  3. hemoglobin ≥ 10 g\u002FdL, independent of transfusion ≤14 days of screening\n  4. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN\n  5. total bilirubin ≤ 1.5 × ULN; \\\u003C 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome\n  6. serum albumin ≥ 30 g\u002FL (3.0 g\u002FdL)\n  7. serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin using the Cockcroft Gault formula\n* Persons of childbearing potential (POCB) or with partners of childbearing potential must be willing to use contraception during study treatment and 6 months after study treatment.\n* Persons are considered to be of childbearing potential unless one or the following applies:\n\n  1. Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause\n  2. Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and\u002For bilateral oophorectomy\n* Voluntary written consent prior to the performance of any research related activity\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Clinical or radiologic evidence of epidural spinal cord compression or radicular pain.\n* Prior radiation therapy to the target lesion.\n* Candidates for spine stabilization surgery.\n* The target lesion(s) is deemed ineligible for RFA\u002FBA (e.g. unstable existing fractures\u002Fimpending fractures, involvement of the posterior elements, retropulsion, spinal canal narrowing, neuroforaminal narrowing, uncontrolled bleeding diathesis, active infection anywhere in the body, or purely blastic tumor). Note: Mixed lytic\u002Fblastic tumors are eligible.\n* The target lesion(s) size or location is beyond RFAs ability to safely perform, at the physician's discretion",{"count":163,"type":19},36,[55],"This is a single-center, randomized controlled pilot study of radiofrequency ablation and bone augmentation (RFA\u002FBA) plus radiotherapy (RT) vs. RT alone in patients with metastatic T5-L5 disease of the spine. Patients will be randomized 2:1 to receive either one treatment of RFA\u002FBA plus RT or RT to evaluate the occurrence of skeletal-related events. Skeletal-related events (SREs) are defined as new clinical or radiologic evidence of pathologic fracture, spinal cord or nerve root compression, pain or instability, and\u002For necessity for additional local intervention (i.e. surgery, repeat RFA\u002FBA or RT) due to persistent or progressive symptoms. Post-treatment follow-up for SREs are assessed at 1, 3, 6, 12, and 24 months.",[25,167],"Bone Pain",[169,170,120,171],"Radiofrequency ablation (RFA)","Bone augmentation (BA)","Metastatic disease of the spine","2025-12-01",{"date":174,"type":36},"2025-12-03",{"date":172,"type":36},{"date":177,"type":19},"2028-06-13",{"name":179,"class":43},"University of Minnesota",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":20,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":44},"100424108","dose-escalated-spine-sbrt-for-localized-metastasis-to-the-spinal-column-100424108","NCT04802603","Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column","Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column","DESSRT","Inclusion Criteria:\n\n* Zubrod Performance Status 0-2\n* Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)\n* Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion\n* Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis\n* For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months\n* Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)\n\nExclusion Criteria:\n\n* Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)\n* Non-ambulatory patients\n* \\>50% loss of vertebral body height or spinal instability to due pathologic compression fracture\n* Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord\n* Rapid neurologic decline\n* Patients for whom an MRI of the spine is medically contraindicated\n* Pregnant women",{"count":53,"type":19},[55],"This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques.\n\nIn standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.",[25,192],"Metastasis Spine",[194,195],"Localized Metastasis","Spinal Column","2025-11-13",{"date":198,"type":36},"2025-11-14",{"date":200,"type":36},"2021-03-14",{"date":202,"type":19},"2029-12-31",{"name":132,"class":43},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":20,"phases":213,"briefSummary":214,"conditions":215,"keywords":228,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100371352","stereotactic-magnetic-resonance-guided-radiation-therapy-100371352","NCT04115254","Stereotactic Magnetic Resonance Guided Radiation Therapy","A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)","Inclusion Criteria:\n\n* Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details.\n* Tumor size ≤ 7cm\n* Age 18 years of older.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Specific eligibility requirements for each disease site with be covered in each specific cohort.\n\nExclusion Criteria:\n\n* Specific exclusion requirements for each disease site with be covered in each specific cohort\n* History of allergic reactions attributed to gadolinium-based IV contrast.\n\n  \\-- Note: If a patient will not receive contrast, this is not applicable\n* Pregnant women are excluded from this study.\n* Severe claustrophobia or anxiety\n* Participants who cannot undergo an MRI",{"count":212,"type":19},397,[55],"This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.\n\n* The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer.\n* Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures",[216,217,218,219,220,221,222,223,224,225,25,226,227],"Pancreas Cancer","Lung Cancer","Renal Cancer","Adrenal Metastases","Prostate Cancer","Liver Metastases","Oligoprogressive Nodal Metastases","Metachronous Nodal Metastases","Synchronous Nodal Metastases","Mesothelioma","Brain Metastases","Borderline Resectable Pancreatic Carcinoma",[229,230,216,217,218,219,220,221,231,232,233,234,235,236],"Magnetic Resonance Imaging (MRI)","MRIdian Linear Accelerator","Oligoprogressive","Metachronous","Synchronous","Spine","Prostate Boost","Pelvic Re Irradiation","2025-11-11",{"date":196,"type":36},{"date":240,"type":36},"2019-10-22",{"date":242,"type":19},"2028-06",{"name":244,"class":43},"Dana-Farber Cancer Institute",2,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":20,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":44},"100528795","phase-2-definitive-radiation-for-high-risk-spine-metastases-100528795","NCT06165419","Definitive Radiation for High-Risk Spine Metastases","A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases","Eligible patients must have:\n\n* Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease\n* Metastatic spine involvement documented by imaging\n* Involvement of maximum 3 contiguous vertebral bodies at the index site\n* Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids\n* An evaluation by an radiation oncology and orthopedic spine\u002Fneurosurgery attending\n* ECOG Performance Status of 0-3\n\nPatients are ineligible if they have:\n\n* An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12\n* Had previous surgery or radiation to address the target spinal metastases\n* Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)",{"count":254,"type":19},26,[22],"This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery",[258,259,260,261,262,263,25,68],"Metastatic Cancer","Metastatic Lung Cancer","Metastatic Breast Cancer","Metastatic Tumor","Metastatic Tumor of Bone","Metastatic Tumor to the Spine","2025-05-09",{"date":266,"type":36},"2025-05-14",{"date":268,"type":36},"2023-12-14",{"date":270,"type":19},"2026-05-31",{"name":272,"class":43},"Stony Brook University",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":20,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":245},"100463617","increased-early-pain-relief-by-adding-vertebroplasty-to-sbrt-100463617","NCT05317026","Increased Early Pain Relief by Adding Vertebroplasty to SBRT","Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief","Inclusion Criteria:\n\n* Histological evidence of cancer.\n* Spinal and vertebral bone metastases (T5 to L5) documented by imaging.\n* Pain related to metastases ≥ 4 on a numerical scale 0-10.\n* Karnofsky performance index \\> 60 (ecog 0-2)\n* Candidate for SBRT\n* Less than 3 consecutive levels reached.\n* Ability to complete follow-up questionnaires regarding pain, analgesics, and quality of life assessment.\n* Potentially unstable lesions according to the spinal instability neoplastic score (SINS) scale (\\> or = 7)\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Contraindications to MRI.\n* Histology: myeloma, lymphoma or plasmacytoma.\n* Radiotherapy prior to the level to be treated.\n* Previous surgery at the site to be treated.\n* Surgical indication:\n\nspinal instability neoplastic score (SINS) \\> 13 or according to tumor board consensus.\n\nBilsky score \\> or = 2 Severe or progressive neurological signs (motor, incontinence).\n\n* Lesion too large for safe vertebroplasty.\n* High thoracic location not allowing safe visibility in fluoroscopy to perform vertebroplasty (T4 and above).\n* Non-reversible coagulation disorders.\n* Uncontrolled local or systemic infection.\n* Estimated survival of less than 6 months.\n* Inability or refusal to undergo SBRT treatment or vertebroplasty",{"count":281,"type":19},50,[55],"The goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. The added value of vertebroplasty to SBRT is not well documented in the literature, nor whether performing vertebroplasty before radiotherapy treatment leads to a reduction in the rate of fractures and post-SBRT pain.",[25,285,286],"Radiation Therapy","Pain","2024-08-06",{"date":289,"type":36},"2024-08-07",{"date":291,"type":36},"2023-11-22",{"date":293,"type":19},"2027-12-31",{"name":295,"class":43},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":15,"minAge":303,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":20,"phases":306,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":44},"100477317","post-operative-rt-for-limited-spine-metastases-100477317","NCT05495399","Post Operative RT for Limited Spine Metastases","Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy","Inclusion Criteria:\n\n1. Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.\n2. Patients with maximum two continuous level of spine metastases need for surgery are eligible. Patients who have other spine metastases but not necessary for surgery are allowed.\n3. A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.\n4. Patients aged at least 20 years old are eligible.\n5. Life expectancy of ≥ 6 months.\n6. ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment)\n7. No prior RT to the index spine level(s)\n8. Women of childbearing potential 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. Patients received prior radiotherapy to the index spine level.\n2. Patients who cannot receive Gadolinium enhanced MRI due to pacemaker or metal implant or who cannot receive contrast enhanced CT scan due to impaired renal function.\n3. Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.\n4. Patients who cannot tolerate radiotherapy immobilization.\n5. 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. Life-threatening uncontrolled clinically significant cardiac arrhythmias.\n   4. Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects.\n   5. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.\n   6. Uncontrolled psychiatric disorder.\n6. Pregnant or breast-feeding women","20 Years",{"count":305,"type":19},111,[55],"To evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by SBRT or conventional RT. The study primary endpoint is one year local control.",[25],[310,311,312],"Stereotactic body radiotherapy","Spondylectomy","Separation surgery","2024-02-04",{"date":315,"type":36},"2024-02-06",{"date":317,"type":36},"2022-08-01",{"date":319,"type":19},"2027-07",{"name":321,"class":43},"National Taiwan University Hospital"]