[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06204315":3,"trial-entities:NCT06204315":81,"trial-summary:NCT06204315":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":51,"locations":54,"central_contacts":72,"overall_officials":75,"references":77,"see_also_links":78},"NCT06204315","2023-0287","Risk Adapted Spinal Cord\u002FCauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery","RECRUITING","2029-12-31","2026-04","2026-04-16","2024-11-11","M.D. Anderson Cancer Center","OTHER",true,"To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.","Primary Objectives The primary protocol objectives are to establish the safety of CDE-SSRS alone in participants with MESCC. Specifically, we aim to maintain an RM risk no greater than 1%. RM will be defined as non-functional paresis per the McCormick score (i.e., Grade D).\n\nSecondary Objectives Secondary objectives include pain control as measured by the Brief Pain Inventory, quality of life as measured by the EQ-5D, symptom burden as measured by the MDASI-SP, overall survival, toxicity, ambulatory rate and cost-effectiveness. LC will be defined radiographically with serial MRI scans by the study radiologist per SPINO criteria.",[18,19,20],"Spinal Cord","Metastatic Epidural","Spine Stereotactic",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[25],"PHASE2",{"count":27,"type":28},60,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"RADIATION","Stereotactic Radiosurgery","Given by RTx",[32],[36],"CDE-SSRS",[38],{"measure":39,"description":40,"timeFrame":41},"Safety and adverse events (AEs)","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0","Through study completion; an average of 1 year.",[],"ALL","18 Years",null,false,{"inclusion":48,"exclusion":49,"raw_text":50},[],[],"Inclusion Criteria:\n\n1. Greater than or equal to 18 years old\n2. Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration\n3. Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI\n4. All participants must be able to receive single fraction SSRS at the site of interest with 0.01 cc of the spinal cord receiving 14-16 Gy and\u002For 0.01 cc of the cauda equina receiving 18-20 Gy. The goal of treatment is to select the minimal dose to the organ at risk which will achieve a GTV Dmin of 14 Gy at the treating physician's discretion.\n5. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session\n6. All participants must be able to receive a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gy\n7. All participants must have a vertebral level site of interest from C1 to S2\n8. Signed informed consent\n9. Diagnosis of cancer excluding ultra-radiosensitive histologies (see 4.2)\n10. Motor strength ≥ 4 out of 5 in extremity or extremities affected by the level of cord compression\n11. ECOG ≤ 2\n\nExclusion Criteria:\n\n1. Participants with ultra-radiosensitive histologies (lymphoma, multiple myeloma\u002Fplasmacytoma)\n2. Prior history of radiation at the spinal site of interest\n3. Inability to lie supine comfortably for ≥ 60 minutes\n4. Progressive neurological deficits due to compression\n5. Inability of obtain an MRI\n6. Inability or refusal to undergo an MR simulation\n7. No eligible for single fraction SSRS for any reason\n8. Participants who are pregnant",[52,53],"ADULT","OLDER_ADULT",[55],{"facility":56,"status":7,"city":57,"state":58,"zip":59,"country":60,"contacts":61,"geoPoint":69},"MD Anderson Cancer Center","Houston","Texas","77030","United States",[62,67],{"name":63,"role":64,"phone":65,"email":66},"Amol Ghia, MD","CONTACT","832-628-7357","ajghia@mdanderson.org",{"name":63,"role":68},"PRINCIPAL_INVESTIGATOR",{"lat":70,"lon":71},29.76328,-95.36327,[73],{"name":63,"role":64,"phone":74,"email":66},"(832) 628-7357",[76],{"name":63,"affiliation":12,"role":68},[],[79],{"label":56,"url":80},"http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":82,"biomarkers":84},[83],"Metastatic Malignant Neoplasm in the Spine",[],{"nct_id":4,"found":14,"summary":86,"prompt_version":95},{"design":87,"status":88,"heading":6,"summary":89,"follow_up":90,"word_count":91,"commitments":92,"compensation":93,"drugs_mentioned":94},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 participants.","completed","This study is looking at the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) for patients with metastatic epidural spinal cord compression (MESCC). MESCC is when cancer has spread to the spine and is pressing on the spinal cord. The study aims to see if this radiation treatment, Stereotactic Radiosurgery, can be given safely while keeping the risk of serious side effects to the spinal cord low. Researchers will also look at how well it controls pain, improves quality of life, and overall survival. You might be able to join if you are at least 18 years old and have spinal metastasis that is close to your spinal cord or cauda equina, as seen on an MRI. The study is currently recruiting about 60 participants.","Your safety and any side effects will be monitored throughout the study, which is expected to last an average of 1 year.",129,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]