[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578548":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":63,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Menoufia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (mFolfox6)","ACTIVE_COMPARATOR","Chemotherapy (mFolfox6) then radiochemotherapy",[13],"Drug: mFolfox6",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B (mFOLFIRINOX)","EXPERIMENTAL","Chemotherapy (mFOLFIRINOX) then radiochemotherapy",[19],"Drug: mFOLFIRINOX",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","mFOLFIRINOX","Neoadjuvant chemotherapy",[15],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"mFolfox6",[9],[31],{"name":32,"affiliation":5,"role":33},"Yostena Mekhail, MD,PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"E Morkos","CONTACT","00201061323285","yoyonagy7@gmail.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Medicine","RECRUITING","Shibīn al Kawm","Menoufia","32511","Egypt","EG",{"type":50,"coordinates":51},"Point",[52,53],31.00904,30.55258,{"lat":53,"lon":52},[56,61],{"name":57,"role":37,"phone":58,"phoneExt":59,"email":60},"faculty of medicine","0482330325","+20","medcine@menofia.edu.eg",{"name":26,"role":37,"phone":62,"phoneExt":59,"email":26},"0482224819",{"type":33,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"yostena nagy kamel mekhail","Primary Investigator","100578548","phase-2-neoadjuvant-folfirinox-and-preoperative-chemoradiotherapy-for-locally-advanced-rectal-cancer-patients-100578548",false,"NCT06812728","Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients","Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.","Inclusion Criteria:\n\n1. Histologically proven rectal adenocarcinoma.\n2. Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT.\n3. Resectable tumor, or considered as potentially resectable after CRT.\n4. No distant metastases.\n5. Patient eligible for surgery\n6. World Health Organization (WHO)\u002FEastern Cooperative Oncology Group (ECOG) performance status 0\u002F1.\n7. No heart failure or coronary heart disease symptoms (even controlled).\n8. No peripheral neuropathy \\> grade 1.\n9. No prior radiotherapy of the pelvis for any reason and no previous CT\n10. No major comorbidity that may preclude the delivery of treatment\n11. Adequate contraception in fertile patients.\n12. Adequate hematologic function.\n\n13 Adequate hepatic function.\n\n14\\. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Metastatic disease\n2. Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1\n3. Medical history of chronic diarrhea or inflammatory disease of the colon or rectum\n4. Medical history of angina pectoris or myocardial infarction\n5. Other concomitant cancer.\n6. Pregnant or breast-feeding woman.\n7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.","ALL","18 Years","70 Years",{"count":77,"type":78},100,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.",[84],"Rectum Cancer",[86,23,87,88,89,90],"Neoadjuvant","TNT","Watch and wait approach","Complete clinical response","Sphincter sparing","2025-02-15",{"date":93,"type":94},"2025-02-19","ACTUAL",{"date":96,"type":94},"2025-01-25",{"date":98,"type":78},"2027-02-25",{"name":5,"class":6},1]