[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastro-intestinal-intraepithelial-neoplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastro-intestinal-intraepithelial-neoplasia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25,26,27,28],"Colorectal Neoplasms","Breast Neoplasms","Head and Neck Neoplasms","Gastro-Intestinal Intraepithelial Neoplasia",[30,31,32,33,34],"colorectal cancer","breast cancer","head and neck cancer","Gastro-Intestinal cancer","chemotherapy toxicity","RECRUITING","2025-11-11",{"date":38,"type":39},"2025-11-13","ACTUAL",{"date":41,"type":39},"2025-08-27",{"date":43,"type":19},"2029-07-07",{"name":45,"class":46},"Rutgers, The State University of New Jersey","OTHER",12]