[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605103":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":173,"collaborators":26,"id":175,"slug":176,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":26,"eligibilityCriteria":180,"healthyVolunteers":177,"sex":181,"minAge":182,"maxAge":26,"enrollmentInfo":183,"targetDuration":26,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":195,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal DPYD Patients (Control Arm)","ACTIVE_COMPARATOR","Should receive 100% of the standard recommended doses as per the BEACON order plan.\n\nDose Reduction for Toxicity: Reduce doses by 25% for unacceptable Grade 3 or any Grade 4 toxicity or clinically significant laboratory anbormaillity. If this occurs again, an additional 25% reduction (to 50% of the initial doses) should be used.",[13,14],"Drug: Fluorouracil injection","Drug: Xeloda",{"label":16,"type":17,"description":18,"interventionNames":19},"Patients with One DPYD Variant (Heterozygotes)","EXPERIMENTAL","Will receive 50% of the regular starting doses for the first two cycles. For example, for FOLFOX or FOLFIRI, the 5FU bolus would be 200 mg\u002Fm², and the infusion would be 46 hours at 1200 mg\u002Fm².",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fluorouracil injection","Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.",[9,16],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Xeloda",[9,16],[31],{"name":32,"affiliation":33,"role":34},"Howard S. Hochster, MD","Study Principal Investigator","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Howard S Hochster, MD","CONTACT","732-253-5618","howard.hochster@rutgers.edu",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Christian F Misdary","cm1344@cinj.rutgers.edu",[45,61,72,83,94,105,116,124,136,143,151,162],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RWJBarnabas Health Clara Maas Medical Center","RECRUITING","Belleville","New Jersey","07109","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-74.15014,40.79371,{"lat":57,"lon":56},[60],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":62,"status":47,"city":63,"state":49,"zip":64,"country":51,"countryCode":52,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Trinitas Hospital and Comprehensive Cancer Center","Elizabeth","07202",{"type":54,"coordinates":66},[67,68],-74.2107,40.66399,{"lat":68,"lon":67},[71],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":73,"status":47,"city":74,"state":49,"zip":75,"country":51,"countryCode":52,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton","Hamilton","08690",{"type":54,"coordinates":77},[78,79],-74.08125,40.20706,{"lat":79,"lon":78},[82],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":84,"status":47,"city":85,"state":49,"zip":86,"country":51,"countryCode":52,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"RWJBarnabas Health Jersey City Medical Center","Jersey City","07302",{"type":54,"coordinates":88},[89,90],-74.07764,40.72816,{"lat":90,"lon":89},[93],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":95,"status":47,"city":96,"state":49,"zip":97,"country":51,"countryCode":52,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Cooperman Barnabas Medical Center","Livingston","07039",{"type":54,"coordinates":99},[100,101],-74.31487,40.79593,{"lat":101,"lon":100},[104],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":106,"status":47,"city":107,"state":49,"zip":108,"country":51,"countryCode":52,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Jack and Sheryl Morris Cancer Center","New Brunswick","08901",{"type":54,"coordinates":110},[111,112],-74.45182,40.48622,{"lat":112,"lon":111},[115],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":117,"status":47,"city":107,"state":49,"zip":118,"country":51,"countryCode":52,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"RWJBarnabas Health - Robert Wood Johnson University Hospita","08903",{"type":54,"coordinates":120},[111,112],{"lat":112,"lon":111},[123],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":125,"status":47,"city":126,"state":49,"zip":127,"country":51,"countryCode":52,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Cancer Center Initiative","Newark","07103",{"type":54,"coordinates":129},[130,131],-74.17237,40.73566,{"lat":131,"lon":130},[134],{"name":37,"role":38,"phone":135,"phoneExt":26,"email":40},"732-235-5618",{"facility":137,"status":47,"city":126,"state":49,"zip":127,"country":51,"countryCode":52,"cosmosGeoPoint":138,"geoPoint":140,"contacts":141},"University Hospital",{"type":54,"coordinates":139},[130,131],{"lat":131,"lon":130},[142],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":144,"status":47,"city":126,"state":49,"zip":145,"country":51,"countryCode":52,"cosmosGeoPoint":146,"geoPoint":148,"contacts":149},"RWJBarnabas Health Newark Beth Israel Medical Center","07112",{"type":54,"coordinates":147},[130,131],{"lat":131,"lon":130},[150],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":152,"status":47,"city":153,"state":49,"zip":154,"country":51,"countryCode":52,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset","Somerville","08873",{"type":54,"coordinates":156},[157,158],-74.60988,40.57427,{"lat":158,"lon":157},[161],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":163,"status":47,"city":164,"state":49,"zip":165,"country":51,"countryCode":52,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"RWJBarnabas Health - Community Medical Center","Toms River","08755",{"type":54,"coordinates":167},[168,169],-74.19792,39.95373,{"lat":169,"lon":168},[172],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":34,"investigatorFullName":32,"investigatorTitle":174,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Distinguished Professor of Medicine, Director Clinical Oncology Research","100605103","phase-4-dpyd-pharmacogenomics-and-fluoropyrimidine-fp-dose-adjustment-100605103",false,"NCT07158164","DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment","Inclusion Criteria:\n\n* Diagnosis of cancer in either the adjuvant or metastatic setting requiring initial therapy with 5-FU or Capecitabine.\n* DPYD testing performed by a CLIA-certified laboratory (i.e., Guardant 360 or Caris blood testing for genomic profiling, DPYD testing by the Mayo Clinic or other certified laboratory) with results available before starting chemotherapy.\n* DPYD testing results falling into one of the following cohorts for first-line therapy with a fluoropyridine:\n* Study Cohort: Patients with one DPYD variant in one gene (heterozygotes).\n* Control Arm: Patients with normal or wild-type DPYD genes, for comparison, will be treated at the usual 100% dose.\n\n  --FOLFOX regimen (N=50)\n* ECOG Performance Status 0-2.\n* Measurable disease or non-measurable disease allowed, including adjuvant 5-FU-based regimens.\n\nExclusion Criteria:\n\n* Patients for whom 5-FU or Capecitabine therapy is contraindicated or not deemed appropriate in the judgment of the treating physician.\n* Patients with two DPYD variants (homozygous deletions or non-functional genetic variants, or double heterozygotes with two different abnormalities) should not receive 5-FU or Capecitabine and are therefore excluded from the study.\n* Pregnant Women and Children","ALL","18 Years",{"count":184,"type":185},100,"ESTIMATED","INTERVENTIONAL",[188],"PHASE4","To prospectively evaluate the efficacy and safety of DPYD-guided dosing strategies in a real-world clinical setting, specifically by comparing the incidence of severe (Grade 3 and 4) fluoropyrimidine-related toxicities of heterozygous DPYD variant patients assigned to DPYD-guided reduced dosing versus patients with standard dosing in the control arm.",[191,192,193,194],"Colorectal Neoplasms","Breast Neoplasms","Head and Neck Neoplasms","Gastro-Intestinal Intraepithelial Neoplasia",[196,197,198,199,200],"colorectal cancer","breast cancer","head and neck cancer","Gastro-Intestinal cancer","chemotherapy toxicity","2025-11-11",{"date":203,"type":204},"2025-11-13","ACTUAL",{"date":206,"type":204},"2025-08-27",{"date":208,"type":185},"2029-07-07",{"name":5,"class":6},12]