[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560283":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":55,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":29,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Al-Azhar University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"modified FOLFOXIRI plus target therapy","EXPERIMENTAL","* Pre-Treatment Medications:\n\n  1. Atropine SC: Administered before irinotecan infusion to prevent side effects.\n  2. High-Risk Anti-Emetics Regimen: Used to prevent acute and delayed vomiting.\n* Chemotherapy Regimen: All eligible patients will receive the modified FOLFOXIRI regimen as follows:\n\n  * Oxaliplatin: 85 mg\u002Fm² IV over 2 hours (Day 1)\n  * Irinotecan: 150 mg\u002Fm² IV over 90 minutes (Day 1)\n  * 5-FU: 2400 mg\u002Fm² IV over 48 hours infusion (Days 1)\n* Targeted Therapy: Administered according to NRAS\u002FKRAS status and the location of the primary tumor:\n\n  * KRAS\u002FNRAS\u002FBRAF Wild-Type (Left-Sided Tumor): Anti-EGFR treatment with either Panitumumab (6 mg\u002Fkg over 60 minutes, Day 1) or Cetuximab (500 mg\u002Fm², Day 1).\n  * KRAS\u002FNRAS Mutant or Right-Sided Tumor: Bevacizumab at a dose of 5 mg\u002Fkg IV over 30 to 90 minutes (Day 1).\n* Treatment Schedule: The treatment will be administered biweekly for a maximum of 12 cycles (6 months).",[13],"Drug: FOLFOXIRI Protocol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","FOLFOXIRI Protocol","as mentioned in Arm description",[9],[21,22,23,24],"Panitumumab","Bevacizumab","Cetuximab","modified FOLFOXIRI",null,[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Al Hussien University Hospital","RECRUITING","Cairo","Cairo Governorate","11311","Egypt","EG",{"type":36,"coordinates":37},"Point",[38,39],31.24967,30.06263,{"lat":39,"lon":38},[42,47,50,53],{"name":43,"role":44,"phone":45,"phoneExt":25,"email":46},"Mohamed Soliman","CONTACT","+2025063560","mohamed.abdelaziz077@gmail.com",{"name":48,"role":49,"phone":25,"phoneExt":25,"email":25},"Mohamed A Abdelaziz","PRINCIPAL_INVESTIGATOR",{"name":51,"role":52,"phone":25,"phoneExt":25,"email":25},"Wael H El Sheshtawy","SUB_INVESTIGATOR",{"name":54,"role":52,"phone":25,"phoneExt":25,"email":25},"Hassan KH Hamdy",{"type":49,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Mohamed Ahmed Abdelaziz","Specialist of Oncology","100560283","phase-2-modified-folfoxiri-plus-target-therapy-as-a-first-line-treatment-for-advanced-colorectal-cancer-a-prospective-phase-two-study-100560283",false,"NCT06575127","Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study","Inclusion Criteria:\n\nHistologically confirmed unrespectable or metastatic colorectal cancer with or without primary tumor in situ.\n\n* Patients were required to have measurable disease according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) (Eisenhauer EA,2009)\n* ECOG PS 0-1 better to exclude PS II as this protocol is known to be toxic\n* Adequate baseline hematology and clinical chemistry labs\n* Adequate cardiac function\n\nExclusion Criteria:\n\n* Double Malignancy\n* DPYD mutant patients\n* Peripheral neuropathy grade 3 or higher patient due to other comorbidities\n* Inflammatory bowel syndrome or any other chronic GIT disease\n* Prior exposure to chemotherapy treatment for colorectal cancer in the metastatic setting\n* Patients who have contraindications for one or more of the study protocol drugs","ALL","18 Years","65 Years",{"count":68,"type":69},60,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","This prospective Phase II study aims to evaluate the efficacy and safety of a modified FOLFOXIRI regimen in the treatment of metastatic colorectal cancer (MCRC). FOLFOXIRI, though effective, is known for its high toxicity, necessitating close monitoring and dose adjustments. .\n\nThe primary endpoint is to assess the impact on the objective response rate and evaluate both acute and delayed toxicity. The secondary endpoints include studying the treatment's effectiveness as conversion therapy, along with disease-free survival (DFS) and overall survival (OS). The tertiary endpoint focuses on evaluating predictive and prognostic factors of significance.\n\nThis study seeks to balance the efficacy of FOLFOXIRI with a modified dose to minimize toxicity while maintaining therapeutic benefits, providing a potentially safer and effective option for patients with MCRC.",[75,76],"Neoplasm Malignant","Colon Cancer Stage 4",[78,79,80],"Colon Cancer","MCRC","FOLFOXIRI","2024-08-26",{"date":83,"type":84},"2024-08-28","ACTUAL",{"date":86,"type":84},"2024-08-17",{"date":88,"type":69},"2026-09-01",{"name":5,"class":6},1]