[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471487":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":111,"collaborators":18,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":18,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":18,"enrollmentInfo":123,"targetDuration":18,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Palliative radiation dose escalation","EXPERIMENTAL","The prescribed dose is 50 Gy in 10 fractions. The total dose can be reduced to 40 Gy and the total number of fractions can be reduced to 8 fractions in non-spine metastases to achieve the normal tissue constraints.",[13],"Biological: EXTERNAL BEAM RADIATION",{"label":15,"type":16,"description":17,"interventionNames":18},"Therapeutic benefit","NO_INTERVENTION","Radiation will be delivered as per protocol. For participants experiencing unacceptable toxicity related to study treatment, yet obtaining therapeutic benefit, participants will be allowed to continue treatment, if well tolerated at the discretion of the investigator.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BIOLOGICAL","EXTERNAL BEAM RADIATION","A minimum of three daily radiation therapy treatments are required in any given week. Any missed radiation treatments will be made up at the end of the treatment schedule, such that the total number of delivered 5 Gy fractions remains ten.",[9],[26],{"name":27,"affiliation":28,"role":29},"Matthew P Deek, MD","Rutgers Cancer Institute of New Jersey","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","732-253-3941","Deekmp@cinj.Rutgers.edu",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Salma Jabbour, MD","732-253-3961","jabbousk@cinj.rutgers.edu",[40,56,66,77,86,92,102],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RWJBarnabas Health - Robert Wood Johnson University Hospital","NOT_YET_RECRUITING","Hamilton","New Jersey","08690","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-74.08125,40.20706,{"lat":52,"lon":51},[55],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},{"facility":57,"status":58,"city":59,"state":44,"zip":60,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":18},"RWJBarnabas Health - Monmouth Medical Center Southern Campus","RECRUITING","Lakewood","08701",{"type":49,"coordinates":62},[63,64],-74.21764,40.09789,{"lat":64,"lon":63},{"facility":67,"status":58,"city":68,"state":44,"zip":69,"country":46,"countryCode":47,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"RWJBarnabas Health - Saint Barnabas Medical Center","Livingston","10457",{"type":49,"coordinates":71},[72,73],-74.31487,40.79593,{"lat":73,"lon":72},[76],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},{"facility":78,"status":58,"city":79,"state":44,"zip":80,"country":46,"countryCode":47,"cosmosGeoPoint":81,"geoPoint":85,"contacts":18},"Robert Wood Johnson University Hospital","New Brunswick","08901",{"type":49,"coordinates":82},[83,84],-74.45182,40.48622,{"lat":84,"lon":83},{"facility":87,"status":58,"city":79,"state":44,"zip":88,"country":46,"countryCode":47,"cosmosGeoPoint":89,"geoPoint":91,"contacts":18},"Cancer Institute of New Jersey","08903",{"type":49,"coordinates":90},[83,84],{"lat":84,"lon":83},{"facility":41,"status":58,"city":93,"state":44,"zip":94,"country":46,"countryCode":47,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Somerset","08876",{"type":49,"coordinates":96},[97,98],-74.48849,40.4976,{"lat":98,"lon":97},[101],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},{"facility":103,"status":58,"city":104,"state":44,"zip":105,"country":46,"countryCode":47,"cosmosGeoPoint":106,"geoPoint":110,"contacts":18},"RWJBarnabas Health - Community Medical Center","Toms River","08755",{"type":49,"coordinates":107},[108,109],-74.19792,39.95373,{"lat":109,"lon":108},{"type":29,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Matthew Pierre Deek","Assistant Professor, Radiation Oncology","100471487","phase-2-palliative-dose-escalated-radiation-for-painful-non-spine-bone-metastases-and-painful-non-bone-metas-100471487",false,"NCT05419518","Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas","Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases","Inclusion Criteria:\n\n* Have provided signed informed consent for the trial\n* Aged ≥18 years at the time of informed consent\n* Histologic proof of malignancy\n* Radiologic or histologic evidence of bone metastases or non-bone metastases\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≥3\n* Pain Score ≥ 3\n* Life expectancy of six months or more\n* Willing and able to comply with all aspects of the protocol\n* A female participant is eligible to participate if she is not pregnant and not breastfeeding\n* Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n* A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Metastasis from a highly radiosensitive tumor (eg, lymphoma, myeloma, germ cell tumor)\n* Spinal metastasis\n* Active compression of spinal cord\u002Fcauda equina\n* Previous RT or SBRT to the same site\n* \\> 3 sites requiring radiation treatment","ALL","18 Years",{"count":124,"type":125},124,"ESTIMATED","INTERVENTIONAL",[128],"PHASE2","The investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 40-50% in painful non-spinal bone metastases. Additionally, the investigators hypothesize that utilizing a fractionation scheme with an escalated biologically equivalent dose (BED) will result in a higher proportion of participants responding to treatment, and will also lead to more durable responses. Furthermore, the investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 35-45% in painful non-bone metastases",[131,132],"Neoplasm Metastases","Metastases, Neoplasm",[134,135,136],"Metastase","Bone Neoplasms","Dose Fractionation, Radiation","2026-05-29",{"date":139,"type":140},"2026-06-02","ACTUAL",{"date":142,"type":140},"2023-03-16",{"date":144,"type":125},"2027-04-01",{"name":5,"class":6},7]