[{"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":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100619557","short-interval-postoperative-stereotactic-body-radiation-therapy-sbrt-after-surgical-intervention-for-spine-metastases-100619557",false,"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.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Spine Metastasis","Stereotactic Body Radiation Therapy (SBRT)","NOT_YET_RECRUITING","2026-05-12",{"date":31,"type":32},"2026-05-14","ACTUAL",{"date":34,"type":20},"2026-07-15",{"date":36,"type":20},"2027-10-31",{"name":38,"class":39},"University of California, San Francisco","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"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":50,"type":20},108,[52],"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.",[26],[56,57,58],"spinal metastases","SBRT","Simultaneous Integrated Boost","RECRUITING","2026-03-12",{"date":62,"type":32},"2026-03-17",{"date":64,"type":20},"2026-04",{"date":66,"type":20},"2031-12",{"name":68,"class":39},"Sunnybrook Health Sciences Centre"]