[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gemcitabine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gemcitabine":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100644426","prospective-observational-study-of-outcomes-after-gemcitabine-docetaxel-melphalan-and-carboplatin-with-autologous-stem-cell-transplantation-in-pediatric-relapsedrefractory-germ-cell-tumors-100644426",false,"NCT07662018","Prospective Observational Study of Outcomes After Gemcitabine, Docetaxel, Melphalan, and Carboplatin With Autologous Stem Cell Transplantation in Pediatric Relapsed\u002FRefractory Germ Cell Tumors","Inclusion Criteria\n\n* Male or female participants, greater than 1 month of age up to 21 years old. Neonates (birth to 1 month of age) will not be enrolled on this protocol.\n* Participants with relapsed\u002Frefractory seminomatous or nonseminomatous GCT who undergo an autologous stem cell transplantation (ASCT) with conditioning therapy including gemcitabine, docetaxel, melphalan, carboplatin (GemDMC) for germ cell tumors\n* As part of our analysis, we will also include participants aged 0-21 years old who have previously underwent ASCT with GemDMC\n* Participants who receive the following regimen:\n\nHigh dose chemotherapy (HDC) course #1:\n\nGemcitabine\u002FDocetaxel\u002FMelphalan\u002FCarboplatin D-6 Admission and start hydration D-5 Gemcitabine 1,500 mg\u002Fm2 IV Docetaxel 275 mg\u002Fm2 IV D-4 Gemcitabine 1,500 mg\u002Fm2 IV Melphalan 20 mg\u002Fm2 IV Carboplatin 250 mg\u002Fm2 IV D-3 Gemcitabine 1,500 mg\u002Fm2 IV Melphalan 20 mg\u002Fm2 IV Carboplatin 250 mg\u002Fm2 IV D-2 Gemcitabine 1,500 mg\u002Fm2 IV Melphalan 20 mg\u002Fm2 IV Carboplatin 250 mg\u002Fm2 IV D-1 Rest D0 Stem Cell infusion\n\nFollowed by HDC course #2 consisting of:\n\nHigh-dose course #2: Carboplatin\u002FEtoposide D-6 Admission and start hydration D-5 to -3 Etoposide 750 mg\u002Fm2 IV Carboplatin 700 mg\u002Fm2 IV D-2 Rest D-1 Rest D0 Stem Cell infusion\n\nExclusion Criteria\n\n* Participants who do not or did not receive GemDMC as part of the conditioning regimen for an ASCT are not eligible for this study","ALL","21 Years",{"count":18,"type":19},30,"ESTIMATED","OBSERVATIONAL","To collect information about treatment outcomes in pediatric and adolescent patients with relapsed\u002Frefractory germ cells tumors who receive GemDMC with an ASCT.",[23,24,25,26,27,28,29,30],"Prospective Observational Study","Gemcitabine","Docetaxel","Melphalan","Carboplatin","Stem Cell Transplantation","Pediatric Relapsed","Refractory Germ","RECRUITING","2026-06-17",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":35},"2026-06-05",{"date":39,"type":19},"2033-12-31",{"name":41,"class":42},"M.D. Anderson Cancer Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100589912","phase-3-perioperative-durvalumab-with-neoadjuvant-ddmvac-or-gemcitabinecisplatin-in-patients-with-muscle-invasive-bladder-cancer-niagara-2-100589912","NCT06960577","Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine\u002FCisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem\u002FCis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","Inclusion Criteria:\n\n* Participants with clinical tumour stage T2-T4aN0\u002F1M0 or T1N1M0 with transitional or mixed transitional cell histology\n* Patients must be planning to undergo radical cystectomy\n* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer\n* ECOG performance status of 0 or 1\n* Minimum life expectancy of 12 weeks at first dose of study medication\n\nExclusion criteria:\n\n* Evidence of lymph node (N2-N3) or metastatic (M1) disease\n* Inoperable tumour(s) with fixation to the pelvic wall on clinical examination\n* Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab\n* Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem\u002Fcis).\n* Uncontrolled intercurrent illness.","18 Years",{"count":53,"type":19},150,"INTERVENTIONAL",[56],"PHASE3","The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine\u002Fcisplatin) in a clinical practice setting.",[59,60,61,62,63,64,24],"Urinary Bladder Neoplasms","Immune Checkpoint Inhibitors","Methotrexate","Vinblastine","Doxorubicin","Cisplatin",[66,67,68,69,70,71,24,64],"Muscle-invasive Bladder Cancer","Bladder Cancer","Immunotherapy","Durvalumab","Perioperative Durvalumab","ddMVAC","2026-06-10",{"date":74,"type":35},"2026-06-11",{"date":76,"type":35},"2025-05-15",{"date":78,"type":19},"2028-10-31",{"name":80,"class":81},"AstraZeneca","INDUSTRY",59,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":91,"minAge":51,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":54,"phases":94,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":43},"100528111","phase-3-evaluation-of-concomitant-chemo-radiotherapy-with-cisplatine-vs-gemcitabin-in-locally-advanced-cervicouterine-cancer-100528111","NCT06156514","Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer","Evaluation of Concomitant Chemo-radiotherapy With Cisplatin vs Gemcitabine as the First Line of Treatment in Patients With Locally Advanced Cervical Cancer, With Comorbidities and Preserved Renal Function, is a Phase III Clinical Trial.","MICHELE","Inclusion Criteria:\n\n* Singed informed consent.\n* Women with Age ≥ 18 years.\n\n  1. -In women of childbearing age it should be documented: a) negative pregnancy test in serum at the beginning of the study (14 days before the start of QT-RT); b) Accept the use of some method of contraception approved by your attending physician during the study and 12 weeks after the treatment has ended.\n  2. -In postmenopausal women (surgical or natural menopause) at least one of the following parameters must be met for inclusion.\n* Previous bilateral oophorectomy\n* Age ≥ 60 years\n* Age \\\u003C60 years and amenorrhea for at least 12 months and levels of follicle stimulating hormone and estradiol within postmenopausal interval parameters.\n* Diagnosis of CaCu EC IB2 mg\u002Fdl With histological confirmation (epidermoid, adenocarcinoma or adenoescamoso).\n* Patients who are candidates for treatment with concomitant QT \u002F RT.\n* ECOG 0-2.\n* Measurable disease by CT scan and magnetic resonance imaging of the pelvis according to the RECIST criteria v1.1\n* No previous treatment.\n* Creatinine clearance ≥ 60 ml \u002F min calculated by the CKD-EPI formula.\n* Patients with adequate hematological and hepatic functioning, defined by the following parameters:\n\n  1. Hb equal to or greater than 10g \u002Fl. (Transfusion prior to treatment is allowed to reach this level of hemoglobin).\n  2. Leukocytes greater than or equal to 4000 \u002F mm3.\n  3. Platelets equal to or greater than 100,000mm3.\n  4. Total bilirubin ≤1.5 times the upper limit of normal (ULN) and. Transaminases less than 1.5 times the LSN\n* Patients with a prior diagnosis of the following comorbidities:\n\n  * Diabetes mellitus type 2, which has: fasting serum glucose \\\u003C250 mg\u002Fdl.\n  * Systemic arterial hypertension G1 or G2 according to CTCAE v4.03\n  * Child Pugh A liver disease\n  * Cardiovascular diseases such as: Ischemic heart disease undergoing asymptomatic treatment, without clinical data of stable or unstable angina or for acute myocardial infarction.\n  * Compensated heart failure in functional class I of the New York Heart Association.\n  * Systemic Lupus Erythematosus with mild or inactive lupus activity (less than or equal to 4 points according to the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI).\n\nExclusion Criteria:\n\n* Patients with a second neoplasm.\n* Pregnant or lactating patients.\n* Patients with small cell and \u002F or neuroendocrine CaCu.\n* Patients with impaired renal function with a GFR \\\u003Cor equal to 60ml \u002F min calculated by the CKD-EPI formula\n* Patients with a history of active TB (TB)\n* Patients with a history of Human Immunodeficiency Virus (HIV) infection\n* Patients with vesico-vaginal or vesicorectal fistulas at diagnosis\n* Concomitant treatment with another experimental drug. Social, family or geographical conditions that suggest a poor attachment to the study\n\nCriteria Interruption of Treatment (Withdrawal of patients)\n\nA patient will be discontinued from the study under the following circumstances:\n\n* Evidence of disease progression.\n* If treating physician considers that a change of therapy may benefit the patient.\n* If patient withdrew consent\n* Due to unmanageable toxicity By pregnancy or if the patient does not wish to continue using the contraceptive methods indicated by the attending physician","FEMALE",{"count":93,"type":19},140,[56],"The purpose of this phase III clinical trial, is to evaluate the efficacy and safety of concomitant chemo-radiotherapy with Cisplatin vs Gemcitabine as the first line of treatment in patients with locally advanced cervical cancer, with comorbidities and preserved renal function.",[97,24,98],"Locally Advanced Cervical Cancer","Chemo-radiotherapy",[100,101,24,64,102],"Locally advanced cervical cancer (LACC)","Concomitant chemo-radiotherapy","Comorbidities","2025-05-22",{"date":105,"type":35},"2025-05-28",{"date":107,"type":35},"2019-11-06",{"date":109,"type":19},"2029-12-31",{"name":111,"class":112},"National Institute of Cancerología","OTHER_GOV"]