[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100405119":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":68,"collaborators":71,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":27,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":27,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":48,"whyStopped":27,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Chongqing University Cancer Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard treatment group","ACTIVE_COMPARATOR","Standard chemoradiation (Pelvic EBRT\u002FExtended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy±pembrolizumab).",[13],"Radiation: Standard chemoradiation±pembrolizumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental group","EXPERIMENTAL","Open\u002Fminimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT\u002FExtended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy±pembrolizumab).",[19,20],"Procedure: Lymph node dissection","Radiation: Chemoradiation± pembrolizumab",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Lymph node dissection","Open\u002Fminimaly invasive pelvic and para-aortic lymph node dissection",[15],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"RADIATION","Standard chemoradiation±pembrolizumab","1\\. A point\u002FHCR-CTV D90≥80Gy(+20%).2. Extended-field EBRT: image-positive common iliac LN with SD≥10mm and\u002For image-positive PALN.3. Target doses for the image-positive nodes can range from 55 to 60Gy.4. Concurrent 5 cycles platinum-containing chemotherapy(Cisplatin 40mg\u002Fm2 q1w or Carboplatin AUC=2 q1w).5. CCRT will be completed in 56 days.6. The patients who received combined immunotherapy were treated with pembrolizumab (200mg, q3w, 3 cycles) during CCRT.7.After CCRT if the cervix biopsy shows residual tumor and\u002For imaging indicates that there are still positive LN with SD≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TAX 135mg\u002Fm2, DDP 50mg\u002Fm2, q3w or TAX 135mg\u002Fm2, CBP AUC=4, q3W) ± brachytherapy (if point A or HR-CTV D90 \\\u003C 96Gy) ± pembrolizumab(suitable for the patients who combined immunotherapy,200mg, q3w, 3 cycles) will be performed.8.Maintenance treatment with pembrolizumab (400mg, q6w) is optional for the combined immunotherapy patiants.",[9],{"type":29,"name":34,"description":31,"armGroupLabels":35,"otherNames":27},"Chemoradiation± pembrolizumab",[15],[37],{"name":38,"affiliation":5,"role":39},"Dongling Zou, M.D.","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":44},"CONTACT","13657690699","cqzl_zdl@163.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Chongqing Cancer Hospital","RECRUITING","Chongqing","Chongqing Municipality","400030","China","CN",{"type":55,"coordinates":56},"Point",[57,58],106.55771,29.56026,{"lat":58,"lon":57},[61,62,63,65],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":44},{"name":38,"role":39,"phone":27,"phoneExt":27,"email":27},{"name":64,"role":39,"phone":27,"phoneExt":27,"email":27},"Ying Tang, M.D.",{"name":66,"role":67,"phone":27,"phoneExt":27,"email":27},"Misi He, M.M.","SUB_INVESTIGATOR",{"type":39,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Dongling Zou","Director of Gynecologic Oncology Department",[72,74,76,78,80,82,84,86,88,91,93,95,97,99,101,103,105,107,109,111,113,115,117],{"name":73,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"name":75,"class":6},"Jiangxi Provincial Cancer Hospital",{"name":77,"class":6},"Anhui Provincial Cancer Hospital",{"name":79,"class":6},"The Second Affiliated Hospital of Harbin Medical University",{"name":81,"class":6},"Hebei Medical University Fourth Hospital",{"name":83,"class":6},"Zhejiang Cancer Hospital",{"name":85,"class":6},"Women's Hospital School Of Medicine Zhejiang University",{"name":87,"class":6},"Qilu Hospital of Shandong University",{"name":89,"class":90},"Fujian Cancer Hospital","OTHER_GOV",{"name":92,"class":6},"Sichuan Cancer Hospital and Research Institute",{"name":94,"class":6},"Cancer Hospital of Guizhou Province",{"name":96,"class":6},"West China Second University Hospital",{"name":98,"class":6},"Tongji Hospital",{"name":100,"class":6},"The Affiliated Ganzhou Hospital of Nanchang University",{"name":102,"class":6},"First Affiliated Hospital of Gannan Medical University",{"name":104,"class":6},"Gansu Provincial Maternal and Child Health Care Hospital",{"name":106,"class":6},"Third Affiliated Hospital of Xinjiang Medical University",{"name":108,"class":6},"Affiliated Cancer Hospital of Shantou University Medical College",{"name":110,"class":6},"Obstetrics & Gynecology Hospital of Fudan University",{"name":112,"class":6},"The Second Affiliated Hospital of Dalian Medical University",{"name":114,"class":6},"Fujian Maternity and Child Health Hospital",{"name":116,"class":6},"Shandong Cancer Hospital and Institute",{"name":118,"class":6},"Sun Yat-Sen University Cancer Center","100405119","the-efficacy-of-lymph-node-dissection-for-stage-iiicr-of-cervical-cancercqgog0103-100405119",false,"NCT04555226","The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)","Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer","Inclusion Criteria:\n\n1. Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma\n2. Cervical cancer stage IIICr (confirmed by CT\u002FMRI\u002FPET\u002FCT) and the short diameter of image-positive lymph node ≥15mm\n3. ECOG score 0\\~1\n4. Expected survival over 6 months\n5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial\n6. No surgical contraindication\n\nExclusion Criteria:\n\n1. Activity or uncontrol severe infection\n2. Active hepatitis B, Liver cirrhosis, Decompensated liver disease\n3. History of immune deficiency, including HIV positive or suffering from other immunodeficiency disease\n4. Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressive medications). Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) were not counted as systemic therapies, and subjects were permitted to use these therapies\n5. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n6. Chronic renal insufficiency or renal failure\n7. Has combined with other malignant tumor which diagnosed within 5 years and\u002For needed to be treated\n8. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure\n9. Has had an allogenic tissue\u002Fsolid organ transplant\n10. A history of pelvic artery embolization\n11. A history of pelvic radiotherapy\n12. A history of partial hysterectomy or radical hysterectomy\n13. A history of immunotherapy or undergoing immunotherapy\n14. A history of severe allergic reactions to platinum-based chemotherapy drugs, pembrolizumab and\u002For any excipients\n15. During the treatment for complications, the drugs which lead to serious liver and\u002For kidney function impairment need to be used, such as tuberculosis","FEMALE","18 Years","70 Years",{"count":130,"type":131},452,"ESTIMATED","INTERVENTIONAL",[134],"NA","This is an national, prospective, multicenter and randomized clinical study designed to determine if patients with stage IIICr of cervical cancer have longer PFS and\u002For OS with lymph node dissection before CCRT when compared to CCRT.",[137],"Cervical Cancer",[139,24,140,141],"Stage IIICr of cervical cancer","Chemoradiation","PFS","2025-08-25",{"date":144,"type":145},"2025-09-02","ACTUAL",{"date":147,"type":145},"2021-01-11",{"date":149,"type":131},"2032-08",{"name":5,"class":6},1]