[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605103":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":172,"collaborators":26,"id":174,"slug":26,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":26,"eligibilityCriteria":178,"healthyVolunteers":175,"sex":179,"minAge":180,"maxAge":26,"enrollmentInfo":181,"targetDuration":26,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":193,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"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",[45,60,71,82,93,104,115,123,135,142,150,161],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RWJBarnabas Health Clara Maas Medical Center","RECRUITING","Belleville","New Jersey","07109","United States",{"type":53,"coordinates":54},"Point",[55,56],-74.15014,40.79371,{"lat":56,"lon":55},[59],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":61,"status":47,"city":62,"state":49,"zip":63,"country":51,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Trinitas Hospital and Comprehensive Cancer Center","Elizabeth","07202",{"type":53,"coordinates":65},[66,67],-74.2107,40.66399,{"lat":67,"lon":66},[70],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":72,"status":47,"city":73,"state":49,"zip":74,"country":51,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton","Hamilton","08690",{"type":53,"coordinates":76},[77,78],-74.08125,40.20706,{"lat":78,"lon":77},[81],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":83,"status":47,"city":84,"state":49,"zip":85,"country":51,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"RWJBarnabas Health Jersey City Medical Center","Jersey City","07302",{"type":53,"coordinates":87},[88,89],-74.07764,40.72816,{"lat":89,"lon":88},[92],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":94,"status":47,"city":95,"state":49,"zip":96,"country":51,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Cooperman Barnabas Medical Center","Livingston","07039",{"type":53,"coordinates":98},[99,100],-74.31487,40.79593,{"lat":100,"lon":99},[103],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":105,"status":47,"city":106,"state":49,"zip":107,"country":51,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Jack and Sheryl Morris Cancer Center","New Brunswick","08901",{"type":53,"coordinates":109},[110,111],-74.45182,40.48622,{"lat":111,"lon":110},[114],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":116,"status":47,"city":106,"state":49,"zip":117,"country":51,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"RWJBarnabas Health - Robert Wood Johnson University Hospita","08903",{"type":53,"coordinates":119},[110,111],{"lat":111,"lon":110},[122],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":124,"status":47,"city":125,"state":49,"zip":126,"country":51,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Cancer Center Initiative","Newark","07103",{"type":53,"coordinates":128},[129,130],-74.17237,40.73566,{"lat":130,"lon":129},[133],{"name":37,"role":38,"phone":134,"phoneExt":26,"email":40},"732-235-5618",{"facility":136,"status":47,"city":125,"state":49,"zip":126,"country":51,"cosmosGeoPoint":137,"geoPoint":139,"contacts":140},"University Hospital",{"type":53,"coordinates":138},[129,130],{"lat":130,"lon":129},[141],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":143,"status":47,"city":125,"state":49,"zip":144,"country":51,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"RWJBarnabas Health Newark Beth Israel Medical Center","07112",{"type":53,"coordinates":146},[129,130],{"lat":130,"lon":129},[149],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":151,"status":47,"city":152,"state":49,"zip":153,"country":51,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset","Somerville","08873",{"type":53,"coordinates":155},[156,157],-74.60988,40.57427,{"lat":157,"lon":156},[160],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":162,"status":47,"city":163,"state":49,"zip":164,"country":51,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"RWJBarnabas Health - Community Medical Center","Toms River","08755",{"type":53,"coordinates":166},[167,168],-74.19792,39.95373,{"lat":168,"lon":167},[171],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":34,"investigatorFullName":32,"investigatorTitle":173,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Distinguished Professor of Medicine, Director Clinical Oncology Research","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":182,"type":183},100,"ESTIMATED","INTERVENTIONAL",[186],"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.",[189,190,191,192],"Colorectal Neoplasms","Breast Neoplasms","Head and Neck Neoplasms","Gastro-Intestinal Intraepithelial Neoplasia",[194,195,196,197,198],"colorectal cancer","breast cancer","head and neck cancer","Gastro-Intestinal cancer","chemotherapy toxicity","2025-11-11",{"date":201,"type":202},"2025-11-13","ACTUAL",{"date":204,"type":202},"2025-08-27",{"date":206,"type":183},"2029-07-07",{"name":5,"class":6},12]