[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437454":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":26,"locations":33,"responsibleParty":47,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":63,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":10,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"observation group",null,"All patients will be treated with Nimotuzumab combined with radiotherapy.",[13,14],"Drug: Nimotuzumab","Radiation: EBRT combined with brachytherapy",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DRUG","Nimotuzumab","Patients receive Nimotuzumab: 200mg, intravenous infusion, weekly for 6 weeks.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"RADIATION","EBRT combined with brachytherapy","IMRT\u002FVMAT are adopted. A total dose of 45-50.4 Gy, 1.8\\~2.0Gy\u002Ff, 25\\~ 28F in pelvic and\u002For extension filed. For patients with metastasis in pelvic lymph node and abdominal para-aortic lymph node, the dose of radiation in local lesion will be increased to 60\\~66Gy. For patients at stage IIIB, concurrent radiation will be given in parametrial extension or in the late course the dose will be increased to 60Gy.\n\nBrachytherapy: Three dimensional high dose rate brachytherapy is used with HR-CTV D90 cumulative dose of 80\\~85Gy (EQD2); If the tumor diameter is ≥4cm, HR-CTV D90 cumulative dose is ≥87Gy (EQD2). Brachytherapy combined with external beam radiotherapy will be completed within 8 weeks.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Junjie Wang, MD","CONTACT","010-82266699","5920","junjiewang_edu@sina.com",[34],{"facility":35,"status":10,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":10},"Peking University 3rd Hospital","Beijing","Beijing Municipality","100191","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Junjie Wang","Department director","100437454","study-of-nimotuzumab-combined-with-imrt-in-elder-patients-with-cervical-squamous-cell-carcinoma-100437454",false,"NCT04976478","Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma","A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age≥65 years old\n2. Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018)\n3. At least one measurable lesion according to RECIST 1.1 guideline\n4. Patients are intolerant to or refuse chemotherapy.\n5. No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria:\n\n   Hemoglobin ≥90g\u002FL Absolute count of neutrophils≥2×109\u002FL orwhite blood cell count≥4.0×109\u002FL； Platelet count≥100×109\u002FL； AST≤2.5×ULN ALT≤2.5×ULN TBIL≤1.5×ULN；\n\n   Serum creatinine≤1.5×ULN or CrCl\\> 60 mL\u002Fmin(according toCockcroft-Gault):\n\n   Serum creatinine≤1.5×ULN Female CrCl=(140-Age)×Weight（kg）×0.85 \u002F (72×Scr mg\u002Fdl)\n6. ECOG score 0-2\n7. Expectancy of life is at least 3 months.\n8. Eligible for pelvic MRI examination.\n9. The patients voluntarily received nimotuzumab combined with radiotherapy.\n10. Patients can comply with the protocol and are willing to sign informed consent.\n\nExclusion Criteria:\n\n1. Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy\n2. Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy.\n3. Patients with rectovaginal fistula\u002Fvaginovesical fistula\u002Funcontrolled vaginal bleeding or with fistula risk.\n\n.4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment.\n\n7)Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.\n\n8)Patients with Crohn's disease and ulcerative colitis. 9)Patients are allergic to Nimotuzumab or its compounds. 10)Patients with neurological or psychiatric abnormalities that affect cognitive ability.\n\n11)Intracavitary brachytherapy cannot be performed that was assessed by the investigator.\n\n12)Other factors were assessed by investigators to be unsuitable to this study.","FEMALE","65 Years",{"count":61,"type":62},125,"ESTIMATED","3 Years","OBSERVATIONAL","To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma",[67],"Cervical Squamous Cell Carcinoma","NOT_YET_RECRUITING","2021-07-21",{"date":71,"type":72},"2021-07-26","ACTUAL",{"date":74,"type":62},"2021-07",{"date":76,"type":62},"2026-12",{"name":5,"class":6},1]