[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650363":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":64,"collaborators":27,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":27,"enrollmentInfo":76,"targetDuration":27,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":51,"whyStopped":27,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Blokhin's Russian Cancer Research Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequential Gemcitabine + Docetaxel","EXPERIMENTAL","Participants receive sequential intravesical gemcitabine followed by docetaxel after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months.",[13,14],"Drug: Gemcitabin","Drug: Docetaxel",{"label":16,"type":17,"description":18,"interventionNames":19},"Sequential Gemcitabine + Mitomycin C","ACTIVE_COMPARATOR","Participants receive sequential intravesical gemcitabine followed by mitomycin C after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months.",[13,20],"Drug: Mitomicin C",[22,28,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Gemcitabin","Intravesical gemcitabine 1 g dissolved in 50 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 minutes before drainage.",[9,16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Docetaxel","Intravesical docetaxel 37.5 mg dissolved in 50 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 to 120 minutes following gemcitabine administration.",[9],[33],"Taxotere",{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":27},"Mitomicin C","Intravesical mitomycin C 40 mg dissolved in 40 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 minutes following gemcitabine administration.",[16],[39],{"name":40,"affiliation":41,"role":42},"Vsevolod Matveev, MD, PhD","N.N. Blokhin National Medical Research Center of Oncology","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":27,"email":48},"Nshan Sedrakyan, MD","CONTACT","+79165663100","nick977773@gmail.com",[50],{"facility":41,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Moscow","115522","Russia","RU",{"type":57,"coordinates":58},"Point",[59,60],37.61781,55.75204,{"lat":60,"lon":59},[63],{"name":45,"role":46,"phone":27,"phoneExt":27,"email":27},{"type":65,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100650363","phase-2-sequential-gemcitabine-plus-docetaxel-versus-gemcitabine-plus-mitomycin-c-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer-100650363",false,"NCT07747740","Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer","A Prospective, Randomized, Open-Label, Phase II Trial Comparing Sequential Intravesical Gemcitabine Plus Docetaxel With Sequential Intravesical Gemcitabine Plus Mitomycin C in Patients With BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer","GEMDOC-MMC","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed BCG-unresponsive non-muscle-invasive urothelial bladder cancer (NMIBC).\n3. Complete transurethral resection of bladder tumor (TURBT) before study treatment.\n4. Intermediate- or high-risk NMIBC according to current clinical guidelines.\n5. Candidate for intravesical chemotherapy.\n6. ECOG performance status 0-2.\n7. Adequate hematologic, renal, and hepatic function.\n8. Written informed consent.\n\nExclusion Criteria:\n\n1. Muscle-invasive (≥T2), locally advanced, or metastatic urothelial carcinoma.\n2. Upper urinary tract urothelial carcinoma requiring treatment.\n3. Previous hypersensitivity to gemcitabine, docetaxel, mitomycin C, or formulation components.\n4. Active uncontrolled urinary tract infection.\n5. Pregnancy or breastfeeding.\n6. Concurrent participation in another interventional clinical trial.\n7. Any serious uncontrolled medical condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.","ALL","18 Years",{"count":77,"type":78},228,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","This prospective, randomized, open-label, phase II clinical trial compares two sequential intravesical chemotherapy regimens in patients with bacillus Calmette-Guérin (BCG)-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC) following complete transurethral resection of bladder tumor (TURBT). Participants are randomized in a 1:1 ratio to receive sequential intravesical gemcitabine plus docetaxel or sequential intravesical gemcitabine plus mitomycin C. The primary objective is to compare 12-month event-free survival between treatment groups. Secondary objectives include evaluation of cystectomy-free survival, progression-free survival, treatment safety, tolerability, and patient-reported quality of life.",[84,85],"Non-Muscle-Invasive Bladder Cancer","BCG-Unresponsive Bladder Cancer",[87,29,88,89,90,91,92,93,94],"Gemcitabine","Mitomycin C","Intravesical Chemotherapy","BCG-Unresponsive NMIBC","Randomized Trial","Bladder Preservation","TURBT","Event-Free Survival","2026-07-31",{"date":97,"type":98},"2026-08-05","ACTUAL",{"date":100,"type":98},"2026-07-09",{"date":102,"type":78},"2030-12-30",{"name":5,"class":6},1]