[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552412":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":10,"locations":30,"responsibleParty":42,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":10,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":69,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant radiotherapy+radical surgery",null,"Patients with high-risk UTUC without distant metastases (which can be accompanied by regional lymph node metastases) were selected to receive short-course neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) after completion of biopsy and definitive pathological diagnosis, and to undergo radical surgery within 3 months from completion of the last radiotherapy session",[13],"Radiation: Neoadjuvant radiotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Neoadjuvant radiotherapy and drug therapy+radical surgery","Patients with high-risk UTUC without distant metastases (which may be accompanied by regional lymph node metastases) were selected to receive a short course of neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) + drug therapy after completing a biopsy and making a definitive pathological diagnosis, and to undergo a radical surgical procedure within 3 months from the end of the last radiotherapy session (full-length radical nephroureteral resection + cystocele sleeve resection ) treatment. Pharmacological treatment can be chemotherapy\u002Fimmunotherapy\u002FADC treatment etc.",[13,18],"Combination Product: Neoadjuvant drug therapy",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"RADIATION","Neoadjuvant radiotherapy","Patients with a clear pathological diagnosis of high-risk UTUC were treated with a short course of 5 days of naSBRT: radiotherapy irradiation was directed to the primary lesion on the affected side and to the lymphatic drainage area, with a dose of 25 Gy (5 Gy\\*5 days).The safety of the neoadjuvant radiotherapy dose and regimen can be evaluated by metrological ramping in the initial 5 patients, with subsequent patients following the optimal dose from ramping.",[15,9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"COMBINATION_PRODUCT","Neoadjuvant drug therapy","Patients will concurrently complete at least 2-4 cycles of preoperative neoadjuvant chemotherapy\u002Fimmunotherapy\u002FADCs as well.",[15],[31],{"facility":32,"status":10,"city":33,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":10},"Departmeng of Urology, Peking University First Hospital","Beijing","China","CN",{"type":37,"coordinates":38},"Point",[39,40],116.39723,39.9075,{"lat":40,"lon":39},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Xuesong Li","Director of the Department of Urology","100552412","neoadjuvant-radiotherapy-for-high-risk-utuc-100552412",false,"NCT06472752","Neoadjuvant Radiotherapy for High-risk UTUC","Efficacy and Safety of Neoadjuvant Radiotherapy for High-risk Upper Tract Urothelial Carcinoma: A Single-arm, Open Label, Prospective Cohort Study","LUXUS07","Inclusion Criteria:\n\n·≥18 years old, no gender limits, diagnosed as high-risk UTUC without existing distant metastasis or other malignancies;\n\n* Completed pathological biopsy with a clear pathological diagnosis : including puncture biopsy, ureteroscopy and urine cytology, at least one of which is clearly diagnosed as uroepithelial carcinoma, which may include no more than 50% or more proportion of squamous, adenoid, sarcomatoid differentiation and other special differentiation types;\n* Have the willingness to undergo radical surgical treatment and perioperative adjuvant treatment, have good compliance, and be able to co-operate with the treatment and follow-up plan specified by the clinician;\n* Postoperative life expectancy of at least 6 months; ECOG score ≤ 2.\n\nExclusion Criteria:\n\n* Distant metastases or other malignant neoplastic diseases combined with other malignant neoplasms in the same period had been detected at the time of surgery, or the present was a progression after palliative resection of previous epithelial carcinoma of the urothelium;\n* History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy;\n* Pregnant women or breastfeeding women; or women of childbearing potential who are not using reliable contraception;\n* The presence of active infections in those with pre-existing or coexisting haemorrhagic disorders\n* clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, New York Heart Association (NYHA) class ≥II congestive heart failure, unstable symptomatic arrhythmias, or class ≥II peripheral vascular disease);\n* Psychological, familial, and social factors leading to lack of informed consent.","ALL","18 Years",{"count":57,"type":58},40,"ESTIMATED","OBSERVATIONAL","The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion \\[cT2 and above\\], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with\u002Fwithout drug) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.",[62],"Urothelial Carcinoma of the Renal Pelvis and Ureter",[64,65,66,67,68],"neoadjuvant radiotherapy","UTUC","prospective cohort","microenviroment","neoadjuvant combined therapy","NOT_YET_RECRUITING","2024-06-23",{"date":72,"type":73},"2024-06-25","ACTUAL",{"date":75,"type":58},"2024-06-30",{"date":77,"type":58},"2029-06-30",{"name":5,"class":6},1]