[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06648785":3,"trial-entities:NCT06648785":97,"trial-summary:NCT06648785":101},{"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":19,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":43,"secondary_outcomes":58,"sex":62,"minimum_age":63,"maximum_age":16,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":78,"locations":81,"central_contacts":93,"overall_officials":94,"references":95,"see_also_links":96},"NCT06648785","STUDY00003100\u002FUVMCC2404","Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies","ENROLLING_BY_INVITATION","2026-11","2026-02","2026-02-05","2024-10-21","University of Vermont Medical Center","OTHER",true,"This study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard FOLFOX or CAPOX regimens.",null,[18],"GI Cancers",[20,21,22,23,24,25],"capecitabine","oxaliplatin","GI","chemotherapy","fluoropyrimidine","modified schedule","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},20,"ESTIMATED",[34,39],{"type":35,"name":21,"description":36,"armGroupLabels":37},"DRUG","85 mg\u002Fm2 oxaliplatin",[38],"Modified administration schedule of capecitabine with oxaliplatin",{"type":35,"name":40,"description":41,"armGroupLabels":42},"Fluoropyrimidine","oral fluoropyrimidine 1000mg\u002Fm2",[38],[44,48,51,55],{"measure":45,"description":46,"timeFrame":47},"Tolerability","Number of toxicity-related treatment delays Number of dose reductions","115 days",{"measure":49,"description":50,"timeFrame":47},"Toxicity","Severity of acute oxaliplatin reactions, graded 1-4",{"measure":52,"description":53,"timeFrame":54},"Neuropathy","Neuropathy will be graded 1-4 after 2 \\&4 months of severity","2-4 months after therapy",{"measure":56,"description":57,"timeFrame":47},"Cytopenias","Frequency of cytopenia grade 3 or higher.",[59],{"measure":60,"description":61,"timeFrame":47},"Tumor response","Response rate after 3-4 months, with exact time of restaging per investigator choice and investigator usual practice","ALL","18 Years",false,{"inclusion":66,"exclusion":69,"raw_text":77},[67,68],"Patient with GI malignancy","Provider plans non-curative intent treatment with either CAPOX or FOLFOX (mFOLFOX6) at standard dosages for \\>3 months NOTE: Patient is not required to have radiologically measurable disease. NOTE: Planned administration of other anti-cancer medications (eg bevacizumab, epidermal growth factor receptor antibodies, immunotherapy, tyrosine kinase inhibitors) is allowed.",[70,71,72,73,74,75,76],"Patients not meeting standard hematologic parameters for chemotherapy administration as follows:","Absolute neutrophil count (ANC) ≥ 1500","Platelet count ≥ 100,000 Patients not meeting standard liver function parameters for chemotherapy administration as follows:","AST ≤ 5x ULN","ALT ≤ 5X ULN","Total Bilirubin ≤ 1.5X ULN Patients not meeting standard renal function parameters for chemotherapy administration as follows:","Serum Creatinine ≤ 1.2 or creatinine clearance ≥ 30 ml\u002Fmin NOTE: Planned administration of another cytotoxic chemotherapy (eg irinotecan) is an exclusion.","Inclusion Criteria:\n\n* Patient with GI malignancy\n* Provider plans non-curative intent treatment with either CAPOX or FOLFOX (mFOLFOX6) at standard dosages for \\>3 months NOTE: Patient is not required to have radiologically measurable disease. NOTE: Planned administration of other anti-cancer medications (eg bevacizumab, epidermal growth factor receptor antibodies, immunotherapy, tyrosine kinase inhibitors) is allowed.\n\nExclusion Criteria:\n\n* Patients not meeting standard hematologic parameters for chemotherapy administration as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1500\n  * Platelet count ≥ 100,000 Patients not meeting standard liver function parameters for chemotherapy administration as follows:\n  * AST ≤ 5x ULN\n  * ALT ≤ 5X ULN\n  * Total Bilirubin ≤ 1.5X ULN Patients not meeting standard renal function parameters for chemotherapy administration as follows:\n  * Serum Creatinine ≤ 1.2 or creatinine clearance ≥ 30 ml\u002Fmin NOTE: Planned administration of another cytotoxic chemotherapy (eg irinotecan) is an exclusion.",[79,80],"ADULT","OLDER_ADULT",[82,90],{"facility":12,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"Burlington","Vermont","05401","United States",{"lat":88,"lon":89},44.47588,-73.21207,{"facility":91,"city":83,"state":84,"zip":85,"country":86,"geoPoint":92},"University of Vermont",{"lat":88,"lon":89},[],[],[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Gastrointestinal Malignancies",[],{"nct_id":4,"found":64,"summary":16,"prompt_version":16}]