[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05391126":3,"trial-entities:NCT05391126":16,"trial-summary:NCT05391126":16},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":43,"sex":48,"minimum_age":49,"maximum_age":16,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":65,"locations":68,"central_contacts":84,"overall_officials":89,"references":92,"see_also_links":93},"NCT05391126","MCC-22-GI-125-PMC","GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care","RECRUITING","2027-05","2025-12","2025-12-16","2022-09-28","Reema A. Patel","OTHER",true,"This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (\\*1\u002F\\*28) (heterozygotes) and usual UGT metabolizers (\\*1\u002F\\*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (\\*1\u002F\\*28, \\*1\u002F\\*1) will be randomized to genotype-guided dosing versus usual care.",null,[18,19],"Colorectal Cancer","Pancreatic Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},178,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Irinotecan","Usual dosing per package insert.",[34],"Genocare Guided",[36,37],"Nano-liposomal Irinotecan","Onyvide",[39],{"measure":40,"description":41,"timeFrame":42},"Adverse Events Frequency","To compare the frequency of cycle 1 grade 3-5 adverse effects in individuals with a \\*1\u002F\\*28 or \\*1\u002F\\*1 genotype who receive genotype-guided dosing and to those who are randomized to receive usual care.","6 months",[44],{"measure":45,"description":46,"timeFrame":47},"Overall Survival","To evaluate overall survival between individuals randomized to receive genotype-guided dosing and those who are randomized to receive usual care.","5 years","ALL","18 Years",false,{"inclusion":52,"exclusion":59,"raw_text":64},[53,54,55,56,57,58],"Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.","Prior treatment is allowed, specifically surgery and\u002For radiation and non-irinotecan containing regimens are allowed.","Age ≥ 18 years.","ECOG performance status ≤ 1.","Patients must have adequate organ and marrow function as defined below:","Measurable or non-measurable disease.",[60,61,62,63],"Patients who received prior treatment with irinotecan are excluded.","Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with targeted therapy, in the opinion of the treating physician.","Pregnant women are excluded from this study.","Patients who are not planned for treatment of their cancer.","Inclusion Criteria:\n\n* Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.\n* Prior treatment is allowed, specifically surgery and\u002For radiation and non-irinotecan containing regimens are allowed.\n* Age ≥ 18 years.\n* ECOG performance status ≤ 1.\n* Patients must have adequate organ and marrow function as defined below:\n* Measurable or non-measurable disease.\n\nExclusion Criteria:\n\n* Patients who received prior treatment with irinotecan are excluded.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with targeted therapy, in the opinion of the treating physician.\n* Pregnant women are excluded from this study.\n* Patients who are not planned for treatment of their cancer.",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"University of Kentucky","Lexington","Kentucky","40506","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Yvonne Taul","CONTACT","859-323-2354","Yvonne.Taul@uky.edu",{"lat":82,"lon":83},37.98869,-84.47772,[85],{"name":86,"role":78,"phone":87,"email":88},"Reema A Patel, MD","8592186650","reema.patel@uky.edu",[90],{"name":86,"affiliation":70,"role":91},"PRINCIPAL_INVESTIGATOR",[],[]]