[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499240":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":50,"collaborators":19,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":19,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":19,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":19,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Dartmouth-Hitchcock Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Arm","EXPERIMENTAL","All patients in this single-study arm will be exposed to the FOX regimen, an adaptively dose-escalated chemotherapy regimen. The FOX regimen is comprised of oxaliplatin 85 mg\u002Fm2 IV on Day 1; leucovorin calcium 350 mg IV on Day 1; and infusional 5-FU IV over 46 hours (Days 1 and 2) - starting at a dose of 2,400 mg\u002Fm2 and adaptively adjusted toward a maximum dose of 3,200 mg\u002Fm2 over Cycles 2-4 using a clinical algorithm.",[13],"Other: FOX dose-escalation algorithm",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"FOX dose-escalation algorithm","Chemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Gabriel A Brooks, M.D.","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Research Nurse","CONTACT","603-653-3637","cancer.research.nurse@hitchcock.org",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Lebanon","New Hampshire","03756","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-72.25176,43.64229,{"lat":42,"lon":41},[45,49],{"name":46,"role":27,"phone":47,"phoneExt":19,"email":48},"Gabriel A Brooks, MD","603-650-9474","gabriel.a.brooks@hitchcock.org",{"name":46,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":23,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Gabriel A. Brooks","Associate Professor of Medicine","100499240","individualized-dose-escalation-of-5-fu-for-gastrointestinal-cancer-100499240",false,"NCT05780684","Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer","Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of metastatic or locally advanced\u002Finoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers of the stomach, esophagus, appendix, small bowel, and ampulla)\n* Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration\n* ECOG Performance Status: 0-1\n\nExclusion Criteria:\n\n* Any prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)\n* Prior receipt of systemic chemotherapy in the 6 months prior to Day 1 of Cycle 1 of FOX (other than radiation-sensitizing chemotherapy)\n* Known mismatch repair deficiency or microsatellite instability-high disease\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening\n* Any confirmed second malignancy that is likely to require systemic therapy during the course of the six-month study period, in the opinion of the enrolling investigator\n* Any of the following baseline laboratory abnormalities:\n\n  * Absolute neutrophil count (ANC) \\\u003C 2,500\u002Fmm3\n  * Platelet count \\\u003C 100,000\u002Fmm3\n  * Hemoglobin \\\u003C 9 g\u002FdL\n  * Creatinine \\> 1.5 x ULN\n  * Total bilirubin \\> 1.5 x ULN\n  * AST\u002FALT \\> 5 x ULN\n  * Patients who are unable to provide informed consent\n  * Patients who are pregnant or breastfeeding\n  * Patients who are incarcerated, homeless, or have active substance use disorders","ALL","18 Years",{"count":63,"type":64},36,"ESTIMATED","INTERVENTIONAL",[67],"NA","This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.",[70,71,72,73,74],"Colorectal Cancer","Esophagus Cancer","Appendix Cancer","Small Bowel Cancer","Ampullary Cancer","2026-06-18",{"date":77,"type":78},"2026-06-22","ACTUAL",{"date":80,"type":78},"2023-07-14",{"date":82,"type":64},"2027-12",{"name":5,"class":6},1]