[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496376":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":59,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm",null,"Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy.",[13,14],"Other: Survey","Other: Toxicity Assessments",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"Survey","Patient Reported Outcome (PRO) questionnaire",[9],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Toxicity Assessments","Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).",[9],[25],{"name":26,"affiliation":27,"role":28},"Theodore K Yanagihara","Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Victoria Xu, MD, PhD","CONTACT","+1 984-974-8744","victoria_xu@med.unc.edu",{"name":36,"role":32,"phone":10,"phoneExt":10,"email":37},"Olivia Roberts","olivia_roberts@med.unc.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of North Carolina at Chapel Hill, Department of Radiation Oncology","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-79.05584,35.9132,{"lat":51,"lon":50},[54,57],{"name":55,"role":32,"phone":56,"phoneExt":10,"email":34},"Victoria Xu","984-974-8744",{"name":58,"role":28,"phone":10,"phoneExt":10,"email":10},"Theodore K Yanagihara, MD",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100496376","disease-outcomes-and-toxicities-in-patients-with-gastrointestinal-and-sarcomatous-malignancies-100496376",false,"NCT05743426","Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies","Inclusion Criteria\n\nIn order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\n1. Subject is willing and able to provide written informed consent to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designer.\n2. Age ≥ 18 years at the time of consent.\n3. Histological, cytological, or radiographic evidence\u002Fconfirmation of a gastrointestinal malignancy or sarcoma.\n4. Females with childbearing potential and male subjects with fathering potential are allowed to participate in this study.\n\nExclusion Criteria\n\nAll subjects meeting any exclusion criteria at baseline will be excluded from study participation.\n\n1. Inability or unwillingness to provide informed consent\n2. Patients who state they do not expect to be available or willing to follow up at expected intervals post-treatment","ALL","18 Years",{"count":70,"type":71},180,"ESTIMATED","OBSERVATIONAL","This prospective, single-institution, observational study explores disease outcomes and toxicities in subjects with gastrointestinal malignancies and sarcoma (bone and soft tissue) who are being treated with standard-of-care therapies including radiotherapy.\n\nRecent advances in treatment approaches affected disease outcomes and toxicities. Prospective monitoring of disease outcomes and toxicities using standardized assessments will provide information about recent changes in the standard of care and further refine treatment approaches and prospective clinical trial design.",[75,76],"Sarcoma","Gastrointestinal Cancer",[78,79],"toxicity","survey","2026-03-24",{"date":82,"type":83},"2026-03-30","ACTUAL",{"date":85,"type":83},"2023-03-17",{"date":87,"type":71},"2036-01-01",{"name":5,"class":6},1]