[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491074":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":25,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Traditional Palliation","EXPERIMENTAL","Participant will be randomized to standard radiation",[13],"Radiation: Traditional Palliation",{"label":15,"type":10,"description":16,"interventionNames":17},"Stereotactic body radiotherapy (SBRT)","Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy.",[18],"Radiation: Stereotactic body radiotherapy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Stereotactic body radiotherapy","Participants will receive radiation as per the schedule discussed with the study doctor.",[15],null,{"type":21,"name":9,"description":23,"armGroupLabels":27,"otherNames":25},[9],[29],{"name":30,"affiliation":5,"role":31},"Jay Reddy, MD,PHD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":25,"email":36},"CONTACT","(832) 750-2924","jreddy@mdanderson.org",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-95.36327,29.76328,{"lat":50,"lon":49},[53,56],{"name":54,"role":34,"phone":55,"phoneExt":25,"email":36},"Jay Reddy, MD, PHD","832-750-2924",{"name":54,"role":31,"phone":25,"phoneExt":25,"email":25},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100491074","3-5-fraction-stereotactic-body-radiation-therapy-for-palliation-of-head-and-neck-squamous-cell-carcinoma-the-fast-phase-ii-randomized-trial-100491074",false,"NCT05674396","3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial","Inclusion Criteria:\n\n* Age 18 or older\n* Willing to provide informed consent\n* Histologically confirmed squamous cell carcinoma\n* Primary tumor site in the head and neck (includes oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary gland, and cutaneous subsites as well as tumors of unknown primary site)\n* Ineligible for curative intent treatment after multidisciplinary evaluation (including evaluation by radiation oncologist and surgeon followed by presentation at multidisciplinary tumor board prior to randomization)\n* Prior therapy including radiation, surgery, or systemic therapy is permitted unless further radiation is deemed inappropriate by the enrolling physician\n* Metastatic disease is permitted\n\nExclusion Criteria:\n\n* Contraindications to radiotherapy\n* Pregnant or lactating women\n\n5.0 PRE-TREATMENT EVALUATION\n\n* History and physical examination including laryngopharyngoscopy by a radiation oncologist and\u002For head and neck surgeon within 8 weeks prior to randomization.\n\n  o Clinical examination will include a detailed description of disease target including measurement where feasible to facilitate response assessment\n* Documentation of smoking history\n* Staging imaging within 12 weeks prior to randomization:\n\n  * Contrast-enhanced CT of the neck and chest or\n  * MRI of the neck with CT of the chest or\n  * Whole body PET\u002FCT\n* Histological confirmation of squamous cell carcinoma\n* Pregnancy test for women of child-bearing age, within 2 weeks prior to randomization\n* Assessment of all baseline symptoms, using CTCAE version 5.0 within 2 weeks prior to randomization.\n* Assessment of baseline pain score (NRS) and analgesic use (non-opioid and opioid)\n* Completion of QOL scoring within 2 weeks of randomization\n* Informed consents must be obtained prior to any study specific activities","ALL","18 Years",{"count":68,"type":69},108,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","To learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or \"SBRT\") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.",[75],"Head and Neck Squamous Cell Carcinoma","2026-08-07",{"date":78,"type":79},"2026-08-10","ACTUAL",{"date":81,"type":79},"2023-06-30",{"date":83,"type":69},"2027-09-30",{"name":5,"class":6},1]