[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100359538":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of Siena","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Group","ACTIVE_COMPARATOR","Neoadjuvant chemotherapy + surgical gastrectomy with D2 lymphadenectomy",[13],"Procedure: Gastrectomy with D2 lymphadenectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental Group","EXPERIMENTAL","Neoadjuvant chemotherapy + surgical gastrectomy with D2plus lymphadenectomy",[19],"Procedure: Gastrectomy with D2plus lymphadenectomy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Gastrectomy with D2 lymphadenectomy","Patients who are assigned to the neoadjuvant chemotherapy+ surgical D2 treatment group will undergo either subtotal or total gastrectomy, depending on the location of the primary tumour. Standardized D2-lymph node dissection is required with specific information about lymph node stations.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Gastrectomy with D2plus lymphadenectomy","Patients who are assigned to the neoadjuvant chemotherapy + surgical D2+ extended lymphadenectomy treatment group will undergo either subtotal or total gastrectomy, depending on the location of the primary tumour. Standardized D2+ lymph node dissection plus resection of stations 8p, 12p, 13, 14v, 16a2\u002Fb1 is required with specific information about lymph node stations.",[15],[32],{"name":33,"affiliation":5,"role":34},"Franco Roviello","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Daniele Marrelli","CONTACT","+39577585157","daniele.marrelli@unisi.it",[42],{"facility":43,"status":44,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"General and Surgical Oncology Department, University of Siena","RECRUITING","Siena","53100","Italy","IT",{"type":50,"coordinates":51},"Point",[52,53],11.33064,43.31822,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":34,"investigatorFullName":33,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Full Professor, Clinical Research","100359538","phase-3-standard-versus-super-extended-lymphadenectomy-after-neo-adjuvant-chemotherapy-for-gastric-cancer-100359538",false,"NCT03961373","Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer","Neo-D2plus","Inclusion Criteria:\n\n* Age equal or greater than 18 years\n* IIA-IIIC histologically proven primary gastric adenocarcinoma, before the treatment with NAC. Not including gastro-oesophageal junction\u002Fcardia carcinoma but only Siewert 3, without any previous treatment (surgery and \u002F or chemotherapy) for this diagnosis\n* Lack in CT scan of following:\n\n  1. Mediastinal lymph nodes\n  2. Lung metastases\n  3. Peritoneal metastases\n  4. Liver metastases\n  5. Pleural effusion, ascites\n  6. Metastases to para-aortic lymph nodes No 16a2\u002Fb1\n  7. Metastases to lymph nodes located in the \"posterior\" area (8p, 12 b\u002Fp, 13)\n  8. Extra-regional lymph node metastases\n* ECOG performance status ≤ 2\n* No prior radio- or chemotherapy conflicting with the treatment of gastric cancer\n* No oesophageal invasion, or invasion \\\u003C=3cm\n* Negative peritoneal washing cytology findings and no peritoneal metastases in staging laparoscopy\n* No gastric stump cancer\n* No signs of cervical and subclavear lymph nodes or distal metastases\n* Patient's consent form obtained, signed and dated before beginning specific protocol procedures\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n\nExclusion Criteria:\n\n* Contraindications for any sort of appropriate chemotherapy according to local standards\n* Linitis plastica\n* Second uncontrolled malignant tumour (synchronous or metachronous (last 5 years) other than Cis or mucosal cancer\n* Neoplasms involving the esophago-gastric junction (Siewert types I and II)\n* Expected unresectability after neo-adjuvant treatment or progression in metastases\n* Emergency surgery due to bleeding or perforation\n* Uncontrolled infections\n* Other serious underlying medical conditions that could impair the ability of the patient to participate in the study\n* Pregnant or lactating women\n* Significant neurologic or psychiatric disorders\n* Severe cardiac illness (NYHA class IV)\n* Under treatment of systemic steroids\n* Participation in any other clinical trial that might interfere with the results of this trial\n* Lack of compliance\n* Inability to fill in questionnaires (insufficient command of language, dementia, lack of time)","ALL","18 Years","80 Years",{"count":70,"type":71},539,"ESTIMATED","INTERVENTIONAL",[74],"PHASE3","In this study the patients with histological evidence of adenocarcinoma of the stomach will be screened and, if eligible, submitted to neo-adjuvant chemotherapy (NAC). After conclusions of NAC and obtaining informed consent, they will be registered and randomized to receive surgical D2 vs. D2plus lymphadenectomy.",[77],"Locally Advanced Gastric Cancer","2019-05-21",{"date":80,"type":81},"2019-05-23","ACTUAL",{"date":83,"type":81},"2018-11-05",{"date":85,"type":71},"2028-11-01",{"name":5,"class":6},1]