[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607089":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":52,"collaborators":20,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":20,"overallStatus":75,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Assiut University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Dose-Dense Gemcitabine and Cisplatin (DDGC)","EXPERIMENTAL","Participants will receive four cycles of dose-dense gemcitabine and cisplatin (DDGC) prior to radical cystectomy. Each cycle consists of gemcitabine 1200 mg\u002Fm² intravenously on days 1 and 8, and fractionated cisplatin 35mg\u002Fm² intravenously on day 1and 8, repeated every 14 days. Pegfilgrastim 6 mg subcutaneously will be administered on day 2 of each cycle for growth factor support. Radical cystectomy will be performed 4-6 weeks after completion of chemotherapy.",[13],"Drug: Gemcitabine and Cisplatin (DD GC)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Gemcitabine and Cisplatin (DD GC)","Participants will receive neoadjuvant ddGC, consisting of gemcitabine and cisplatin administered at shortened intervals (e.g., gemcitabine 1200 mg\u002Fm² on days 1 and 8, fractionated cisplatin 35 mg\u002Fm² on day 1and 8, every 14 days) with appropriate growth factor support. A total of four cycles are planned before radical cystectomy.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Amal Rayan, Professor","Assiut University Hospitals, Faculty of medicine, Assiut University","STUDY_DIRECTOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Nehal Suliman, Assistant lecturer","CONTACT","01098019919","nehal.ali95@yahoo.com",{"name":33,"role":29,"phone":20,"phoneExt":20,"email":34},"Doaa Aly, Assistant professor","doaaalygamaal@gmail.com",[36],{"facility":37,"status":20,"city":38,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Assiut university Hospital-Departement of clinical oncology.","Asyut","Egypt","EG",{"type":42,"coordinates":43},"Point",[44,45],31.18368,27.18096,{"lat":45,"lon":44},[48,50],{"name":28,"role":29,"phone":20,"phoneExt":20,"email":49},"Nehal.ali95@yahoo.com",{"name":33,"role":29,"phone":20,"phoneExt":20,"email":51},"Doaaalygamaal@gmail.com",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Nehal Ali Suliman","Assistant lecturer","100607089","phase-2-neoadjuvent-dose-dense-gemcitabine-and-cisplatin-in-muscle-invasive-bladder-cancer-100607089",false,"NCT07184021","Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer","Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer:Results of a Phase 2 Trial","No Acronym","Inclusion Criteria:\n\n* Histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-T4a, N0-N1, M0.\n* Eligible and fit for cisplatin-based chemotherapy (e.g., creatinine clearance ≥ 60 mL\u002Fmin).\n* Candidate for radical cystectomy after neoadjuvant treatment.\n* ECOG performance status 0-1.\n* Adequate bone marrow, liver, and renal function as per institutional standards.\n\nExclusion Criteria:\n\nHistology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%).\n\n* Clinical or radiological evidence of distant metastases (M1).\n* Prior systemic chemotherapy or radiotherapy for bladder cancer.\n* Significant renal impairm ent (creatinine clearance \\\u003C 60 mL\u002Fmin).\n* ECOG performance status ≥ 2.\n* Significant comorbidities contraindicating chemotherapy (e.g., uncontrolled cardiac disease, severe infection).","ALL","18 Years",{"count":67,"type":68},30,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","To evaluate the feasibility, safety, and pathological response of dose-dense neoadjuvant gemcitabine and cisplatin in patients with muscle-invasive bladder cancer, with the goal of improving tumor downstaging and optimizing outcomes before radical cystectomy.",[74],"Urinary Bladder Cancer","NOT_YET_RECRUITING","2025-09-13",{"date":78,"type":79},"2025-09-19","ACTUAL",{"date":81,"type":68},"2025-09",{"date":83,"type":68},"2027-09",{"name":5,"class":6},1]