[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453082":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":53,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Chungnam National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","mFOLFIRINOX",[13],"Drug: mFOLFIRINOX",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B","ACTIVE_COMPARATOR","mFOLFOX 6",[19],"Drug: mFOLFOX 6",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Irinotecan 150 mg\u002Fm2 IV day 1, oxaliplatin 85 mg\u002Fm2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg\u002Fm2 IV day 1, 5-FU 1200 mg\u002Fm2\u002Fd IV x 2 days (total 2400 mg\u002Fm2 over 48 hours) continuous infusion\\] 12 cycles per 2 weeks\n\nmFOLFOX 6 \\[Oxaliplatin 85 mg\u002Fm2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg\u002Fm2 IV day 1, 5-FU 400 mg\u002Fm2 IV bolus day 1, 5-FU 1200 mg\u002Fm2\u002Fd IV x 2 days (total 2400 mg\u002Fm2 over 46-48 hours) continuous infusion, 12 cycles per 2 week",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"Oxaliplatin 85 mg\u002Fm2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg\u002Fm2 IV day 1, 5-FU 400 mg\u002Fm2 IV bolus day 1, 5-FU 1200 mg\u002Fm2\u002Fd IV x 2 days (total 2400 mg\u002Fm2 over 46-48 hours) continuous infusion, 12 cycles per 2 weeks",[15],[30],{"name":31,"affiliation":5,"role":32},"Kyung Ha Lee","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","821042141415","lllllkh@cnuh.co.kr",[39],{"facility":5,"status":40,"city":41,"state":25,"zip":42,"country":43,"countryCode":25,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Daejeon","34112","South Korea",{"type":45,"coordinates":46},"Point",[47,48],127.38493,36.34913,{"lat":48,"lon":47},[51],{"name":31,"role":35,"phone":52,"phoneExt":25,"email":37},"01042141415",{"type":32,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Kyung-ha Lee","Associate professor",[57],{"name":58,"class":59},"Boryung Pharmaceutical Co., Ltd","INDUSTRY","100453082","phase-2-adjuvant-mfolfirinox-for-high-risk-stage-iii-colon-cancer-100453082",false,"NCT05179889","Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer","mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1\u002F2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled, Randomized, Phase II Study","Inclusion Criteria:\n\n1. Age of 20-70 years with an ECOG ≤ 2\n2. Age of 71-75 years with an ECOG = 0\n3. Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2)\n4. Curative radical resection (successful R0 resection) within 60 days before randomization\n5. Adequate organ functions\n\n   * ANC ≥ 2×106 cells\u002FmL\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Platelets ≥ 100×106 cells\u002FmL\n   * Alanine aminotransferase\u002Faspartate aminotransferase ≤2.5 × times the upper limit of normal (ULN)\n   * Serum total bilirubin ≤ 1.5 ULN\n   * Alkaline phosphatase ≤ 2.5 × ULN\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance \\> 50 mL\u002Fmin (Cockcroft-Gault formula)\n6. Able to understand and willing to sign and date written voluntary informed consent form\n7. Life expectancy ≥ 5 years\n\nExclusion Criteria:\n\n1. Distant metastasis\n2. Middle or lower rectal cancer of need for radiotherapy\n3. Postoperative complication of 3 or more grades of Clavien-Dindo classification\n4. Underlying disease or postoperative condition which is contraindication for chemotherapy\n5. Known hypersensitivity reaction to any study treatment component\n6. Familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer\n7. Inflammatory bowel disease\n8. Previous other malignancy which cannot be curatively treated\n9. Pregnancy or breast feeding\n10. Any other situation would exclude the patient from study based on the investigator's opinion","ALL","20 Years","75 Years",{"count":71,"type":72},308,"ESTIMATED","INTERVENTIONAL",[75,76],"PHASE2","PHASE3","A multicenter, open labeled randomized, phase II trial comparing mFOLFIRINOX and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1\u002F2 or pTanyN2) colon cancer",[79],"Colon Cancer Stage III",[81],"High risk stage III (pT4N1\u002F2 or pTanyN2) colon cancer","2026-03-17",{"date":84,"type":85},"2026-03-19","ACTUAL",{"date":87,"type":85},"2021-07-06",{"date":89,"type":72},"2031-03-15",{"name":5,"class":6},1]