[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100341888":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":44,"locations":54,"responsibleParty":71,"collaborators":76,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":27,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":27,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":57,"whyStopped":27,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"ChineseAMS","UNKNOWN",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Involved field irradiation","EXPERIMENTAL","Patients after R0 surgery whose recurrence lesion larger than 5cm in diameter, or largest diameter was less than 5cm but with skip metastasis far from primary tumor or their time-to-recurrence longer than 16 months were assigned to involved field irradiation group. For lesions far from the thoracic stomach, the prescribed dose is 60Gy\u002F2Gy\u002F30f, and for lesions close to the thoracic stomach, the prescribed dose is 59.4-61.2Gy\u002F1.8Gy\u002F33-34f. Chest CT scan is planned at 50Gy. Radiation field should be modified according to the tumor response. Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks. PEG-rhG-CSF (3-6mg) should be given after 48 hours of chemotherapy.If patients received postoperative chemotherapy of paclitaxel and platinum and went through local-regional recurrence within six months, it is allowed to deliver chemotherapy regimens in the second line. Consolidate chemotherapy were adjusted to the patients after radiation therapy.",[13,14,15,16],"Radiation: Involved field irradiation","Drug: Paclitaxel","Drug: Platinum","Drug: PEG-rhG-CSF",{"label":18,"type":10,"description":19,"interventionNames":20},"Elective field irradiation","Patients after R1\u002FR2 surgery or R0 surgery with the recurrence lesion whose diameter was less than 5cm without skip metastasis far from primary tumor and time-to-recurrence shorter than 16 months were assigned to elective field irradiation group. For lesions far from the thoracic stomach, the prescribed dose is 50.4Gy\u002F1.8Gy\u002F28f with a simultaneously integrated boost up to 59.92-62.16Gy\u002F2.14-2.22Gy\u002F28f. For lesions close to the thoracic stomach, the prescribed dose is 50.4Gy\u002F1.8Gy\u002F28f with a sequential boost of 10-12Gy\u002F1.8-2Gy\u002F5-7f. For patients whose planned thoracic stomach V50\\>50%, the dose should be lowered to 45Gy\u002F1.8Gy\u002F25f. Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks. PEG-rhG-CSF should be given in need. If patients received postoperative chemotherapy of TP and went through local-regional recurrence within 6 months, chemotherapy regimens delivered in the second line. Consolidate chemotherapy were adjusted to the patients after radiation therapy.",[21,14,15,16],"Radiation: Elective field irradiation",[23,28,31,36,40],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","Involved field irradiation; intensity-modulated radiation therapy",[9],null,{"type":24,"name":18,"description":29,"armGroupLabels":30,"otherNames":27},"Elective field irradiation; intensity-modulated radiation therapy",[18],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"DRUG","Paclitaxel","Paclitaxel 135-150mg\u002Fm2, d1, every 3 weeks",[18,9],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Platinum","for lobaplatin, 30mg\u002Fm2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg\u002Fm2, d1-2, every 3 weeks;",[18,9],{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":27},"PEG-rhG-CSF","PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy",[18,9],[45,50],{"name":46,"role":47,"phone":48,"phoneExt":27,"email":49},"Zefen Xiao, MD","CONTACT","+86-13621018159","xiaozefen@sina.com",{"name":51,"role":47,"phone":52,"phoneExt":27,"email":53},"Lei Deng, MD","+86-18611766429","dengleipumc@163.com",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Department of Radiation Oncology, National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},[70],{"name":46,"role":47,"phone":27,"phoneExt":27,"email":27},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":75,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Zefen Xiao","Professor","Chinese Academy of Medical Sciences",[77,80,82,84,87,89],{"name":78,"class":79},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"name":81,"class":79},"Tianjin Medical University Cancer Institute and Hospital",{"name":83,"class":79},"Anyang Tumor Hospital",{"name":85,"class":86},"Fujian Cancer Hospital","OTHER_GOV",{"name":88,"class":79},"Peking University Cancer Hospital & Institute",{"name":90,"class":79},"Hebei Medical University Fourth Hospital","100341888","phase-3-salvage-chemoradiation-therapy-for-recurrence-after-radical-surgery-or-palliative-surgery-in-esophageal-cancer-patients-100341888",false,"NCT03731442","Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients","Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial","Inclusion Criteria:\n\n* Locoregional recurrence after radical surgery;\n* Positive resection margin (R1\u002FR2) after surgery;\n* Out-of-field recurrence after adjuvant chemoradiation or radiotherapy;\n* Recurrence after adjuvant chemotherapy;\n* No prior therapy after recurrence;\n* Age 16-70 years;\n* KPS\\>70;\n* No history of drug allergy;\n* Sufficient liver and kidney functions;\n* White blood cell count \\> 4.0\\*10\\^9\u002FL.\n\nExclusion Criteria:\n\n* Age\\>70 or \\\u003C16 years;\n* Pregnancy or lactation;\n* History of drug allergy;\n* Declining informed consent;\n* Insufficient liver or kidney functions, or abnormal CBC test;\n* Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.","ALL","16 Years","70 Years",{"count":102,"type":103},300,"ESTIMATED","INTERVENTIONAL",[106],"PHASE3","Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.",[109],"Esophageal Cancer",[111,112,113],"Salvage therapy","Recurrence","Chemoradiation","2018-12-10",{"date":116,"type":117},"2018-12-12","ACTUAL",{"date":119,"type":117},"2018-11-01",{"date":121,"type":103},"2027-10-31",{"name":75,"class":79},1]