[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spine-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spine-metastasis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,76],{"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":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100647880","phase-4-extended-prophylactic-anticoagulation-following-spinal-surgery-for-metastatic-disease-100647880",false,"NCT07713875","Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease","Inclusion Criteria:\n\n* Age 18 years or older\n* Undergone spinal surgery (any approach) for treatment of vertebral metastatic disease at UPMC Presbyterian, Shadyside, or Mercy Hospital\n* Planned for discharge to home or acute rehabilitation facility (not hospice)\n* Willing and able to provide written informed consent\n* Able to take oral medications\n* Access to a telephone for follow-up calls\n\nExclusion Criteria:\n\n* Already receiving therapeutic anticoagulation for another indication (e.g., atrial fibrillation, prior VTE, mechanical heart valve)\n* Planned initiation of therapeutic anticoagulation within the next 30 days for another indication\n* Known allergy or hypersensitivity to apixaban\n* History of pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding requiring transfusion or endoscopic intervention within the past 6 months)\n* Active bleeding at time of planned enrollment\n* Platelet count less than 50,000\u002Fmm³ at time of enrollment\n* Hemoglobin less than 8 g\u002FdL at time of enrollment\n* Serum creatinine greater than 2.5 mg\u002FdL\n* ALT or AST greater than 3 times the upper limit of normal\n* Total bilirubin greater than 2 times the upper limit of normal\n* Known severe hepatic impairment (Child-Pugh Class C)\n* Pregnancy or breastfeeding\n* Women of childbearing potential unwilling to use adequate contraception during study participation\n* History of proximal gastrointestinal resection (i.e., gastrectomy and\u002For proximal small bowel resection) that might alter oral drug absorption\n* Concurrent use of strong dual inhibitors of CYP3A4 and P-gp or moderate CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin, diltiazem)\n* Concurrent use of strong dual inducers of CYP3A4 and P-gp (rifampin, carbamazepine, phenytoin, St. John's Wort)\n* Inability to safely discontinue all antiplatelet medications for the 30-day study drug period, as determined by the treating cardiologist or prescribing physician (aspirin, clopidogrel, ticagrelor)\n* Inability or unwillingness to discontinue chronic NSAID use during the 30-day study drug period (as-needed use less than 3 days per week is acceptable)\n* Planned surgery or invasive procedure within the next 30 days\n* Hospital length of stay 30 days or greater\n* Prisoner or incarcerated individual\n* Any other condition that, in the investigator's opinion, would make the subject unsuitable for study participation or unable to comply with study procedures","ALL","18 Years",{"count":18,"type":19},50,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","People who have surgery on their spine to treat cancer that has spread (metastatic disease) have a high chance of developing dangerous blood clots in the legs or lungs. These blood clots are called deep vein thrombosis (DVT) or pulmonary embolism (PE). In a review of patients at UPMC who had this type of surgery, about 15 out of 100 developed a blood clot within 90 days of leaving the hospital.\n\nRight now, patients receive blood-thinning medicine only while they are in the hospital after surgery. Once they go home, the medicine is stopped. There are no guidelines telling doctors whether blood-thinning medicine should continue after patients go home from spine surgery for cancer. However, for other types of major cancer surgery, studies have shown that continuing blood-thinning medicine for about 4 weeks after surgery can help prevent blood clots.\n\nThis study will test whether taking a blood-thinning medicine called apixaban (brand name Eliquis) by mouth for 30 days after leaving the hospital can help prevent blood clots in patients who have had spine surgery for cancer that has spread. The dose used in this study (2.5 mg twice a day) is the same dose approved by the U.S. Food and Drug Administration (FDA) for preventing blood clots after hip and knee replacement surgery.\n\nAbout 50 adults at UPMC will take part. Participants will take apixaban for 30 days starting the day after hospital discharge. The study team will call participants by phone three times - about 2 days, 31 days, and 91 days after discharge - to check on their health, ask about any bleeding or blood clot symptoms, and assess medication use. No extra clinic visits are required. Results will be compared to a group of 68 patients who had the same type of surgery in the past but did not take apixaban after leaving the hospital.\n\nThe main goal is to find out if apixaban reduces the rate of blood clots within 90 days of hospital discharge. The study will also track bleeding events and other side effects to determine if this approach is safe. The study hypothesis is that extended blood-thinning medicine after surgery will reduce blood clots compared to the current approach of stopping this medicine at hospital discharge.",[25,26,27,28],"Venous Thromboembolism (VTE)","Deep Vein Thrombosis (DVT)","Pulmonary Embolism (PE)","Spine Metastasis",[30,31,32,33,34,35,36,37,38,39,40],"Apixaban","Eliquis","Extended thromboprophylaxis","Postoperative anticoagulation","Spine surgery","Cancer surgery","VTE prophylaxis","Direct oral anticoagulant","DOAC","Factor Xa inhibitor","Metastatic bone disease","NOT_YET_RECRUITING","2026-07-14",{"date":44,"type":45},"2026-07-20","ACTUAL",{"date":47,"type":19},"2026-08",{"date":49,"type":19},"2027-12",{"name":51,"class":52},"James Bayley","OTHER",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":20,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100619557","short-interval-postoperative-stereotactic-body-radiation-therapy-sbrt-after-surgical-intervention-for-spine-metastases-100619557","NCT07346170","Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases","A Phase 2 Study of Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases","Inclusion Criteria:\n\n1. Participants must have a histologically or cytologically confirmed diagnosis of metastatic malignancy or must have preliminary histology or cytology consistent with a diagnosis of metastatic malignancy.\n2. Participants must be considered candidates for postoperative SBRT by the treating radiation oncologist.\n3. Participants must have undergone, within the past 13 days, or are planned to undergo minimally invasive or open surgery for the management of a spine metastasis.\n4. Disease at any spine level is allowed.\n5. Prior therapy\n\n   1. There is no limit on the number of prior spine surgeries or prior courses of radiotherapy directed at the spine if prior therapies occurred at different spinal levels outside the anticipated treatment field.\n   2. There is no limit on the number of courses or types of radiotherapy for radiation delivered outside the planned treatment field.\n6. Cleared by the primary surgical team for postoperative SBRT, including but not limited to hemodynamic, respiratory, and neurologic stability postoperatively, without immediate postoperative complications noted.\n7. Age ≥18 years.\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%, see Appendix 1) 1 month prior to presentation for surgery.\n9. Estimated survival \\>3 months or survival considered adequate to undergo spine surgery as assessed by the primary surgical team.\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Ability to understand and willingness to comply with treatment schedule, follow-up visits, laboratory testing, and other requirements of the study, including disease assessment by MRI.\n12. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n13. The effects of radiation on the developing human fetus are generally considered detrimental. Because the radiation therapy used in this trial is known to be teratogenic, individuals of reproductive potential must agree to use adequate contraception (e.g., hormonal or barrier methods, abstinence) for the duration of study participation and for at least 120 days after the last administration of radiation therapy. Should a study participant or their partner become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Prior radiation of any type within the anticipated treatment field (prior radiation outside the anticipated field is acceptable as above).\n2. Primary malignancy of the spine (examples: chordoma or sarcoma).\n3. Persistent high-grade metastatic spinal cord compression following surgery (Bilsky Grade 3 or higher).\n4. Involvement of 3 or more contiguous spinal levels.\n5. Involvement of more than 2 non-contiguous spinal levels.\n6. American Spinal Injury Association Impairment Scale (ASIA) Grade 3 status.\n7. Surgery was a biopsy only.\n8. Unable to undergo MRI for any reason.\n9. Estimated survival \\\u003C3 months.\n10. Active infection requiring systemic therapy.\n11. Active wound complication requiring medical intervention.\n12. History of radiation-induced myelopathy from prior spine radiation.\n13. History of a collagen vascular disorder (examples: lupus, scleroderma).\n14. History of psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n15. . A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.",{"count":18,"type":19},[62],"NA","Current guidelines suggest postoperative spine Stereotactic Body Radiation Therapy (SBRT) should be delivered within 2-4 weeks after surgery. This approach is rife with logistical complications that create delays and barriers for patients accessing care. An alternative approach delivers postoperative spine SBRT soon after surgery, starting within a single hospital stay. This study will investigate the effects of short-term postoperative spine SBRT on wound complications in a safety lead-in, then will transition to a phase 2 trial investigating local tumor control.",[28,65],"Stereotactic Body Radiation Therapy (SBRT)","2026-05-12",{"date":68,"type":45},"2026-05-14",{"date":70,"type":19},"2026-07-15",{"date":72,"type":19},"2027-10-31",{"name":74,"class":52},"University of California, San Francisco",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":20,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":75},"100629716","phase-2-a-phase-ii-trial-evaluating-radiation-boost-to-painful-spinal-metastases-100629716","NCT07478289","A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases","OPTimized Dose Escalation With Simultaneous Integrated Boost for High Risk Spinal Metastases: a Prospective Phase II TriAL (OPTIMAL)","OPTIMAL","Inclusion Criteria:\n\n* Histopathologically confirmed solid tumor malignancy, or strong suspicion based on clinical and radiographic examination of malignancy\n* Spinal metastases with paraspinal disease extension documented with MRI and recommended for treatment with SBRT\n* Post-operative SBRT is permitted (after stabilization and\u002For decompression surgery) as long as no prior radiotherapy had been delivered to the spinal level planned for trial treatment and paraspinal disease is present\n* ECOG performance status 0-2\n* Able to tolerate protocol SBRT\n* Age 18 years or older\n* Patient is able and willing to complete the Patient Diary (pain and analgesic use)\n* Consent must be appropriately obtained in accordance with local requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate\n* Patients must be accessible for treatment and follow-up\n* Treatment to begin within 14 days (ideally 7 days) of radiotherapy simulation\n\nExclusion Criteria:\n\n* Extremely radiosensitive histology (seminoma, small cell lung cancer, hematologic primaries)\n* Prior radiotherapy in the spine target of interest\n* Spinal instability as assessed by the Spinal Instability Neoplastic Score with a score of \\> 12\n* Symptomatic cord compression or cauda equine syndrome resulting from bony compression or epidural compression of the spinal cord and cauda equina, respectively. Symptomatic refers to neurologic deficit in the form of motor, bowel or bladder dysfunction\n* Pacemaker, such that MRI cannot be performed or treatment cannot be delivered safely\n* Cytotoxic chemotherapy within 1 week prior to radiotherapy delivery",{"count":85,"type":19},108,[87],"PHASE2","Spine SBRT is considered a standard of care for the treatment of spinal metastases. Compared to conventional radiation therapy, spine SBRT delivers high doses of radiation to the affected areas to the spinal metastases.\n\nThis study is interested in seeing whether an additional 'boost' of radiation, delivered to the affected area in the spine, will result in better long-term control of the tumor; help reduce pain; and reduce long-term side effects of radiation therapy.",[28],[91,92,93],"spinal metastases","SBRT","Simultaneous Integrated Boost","RECRUITING","2026-03-12",{"date":97,"type":45},"2026-03-17",{"date":99,"type":19},"2026-04",{"date":101,"type":19},"2031-12",{"name":103,"class":52},"Sunnybrook Health Sciences Centre"]