[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430558":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":16,"locations":22,"responsibleParty":40,"collaborators":7,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":7,"enrollmentInfo":54,"targetDuration":7,"studyType":57,"phases":7,"briefSummary":58,"conditions":59,"keywords":7,"overallStatus":25,"whyStopped":7,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"Active surveillance","Patients will undergo two clinical response evaluations (CREs) after nCRT. During CRE-1 (5-6 weeks) patients will undergo oesophagogastroduodenoscopy (OGD) with bite-on-bite biopsies. During CRE-2 (10-12 weeks) patients will undergo positron emission tomography with computed tomography (PET-CT), endoscopy with bite-on-bite biopsies and endoscopic ultrasonography (EUS) plus fine-needle aspiration (FNA). If cancer is detected, surgery will be performed. Patients with cCR are eligible for active surveillance where regular CREs are performed to detect regrowth of cancer. Delayed oesophagectomy will be offered to patients with highly suspected or profen locoregional regrowth, without distant metastases. The safety and feasibility of active surveillance depends on several factors monitored in the SANO trial. So far, these stopping rules have not been met. In case one of the stopping rules is reached, further inclusion in the SANO-2 study will be stopped and surgical resection is offered.",[13],{"name":14,"affiliation":5,"role":15},"Bas Wijnhoven, Dr.","PRINCIPAL_INVESTIGATOR",[17],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},"Charlène vd Zijden, Drs.","CONTACT","+31107041223","c.vanderzijden@erasmusmc.nl",[23],{"facility":24,"status":25,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Erasmus University Medical Center","RECRUITING","Rotterdam","South Holland","3015 GD","Netherlands","NL",{"type":32,"coordinates":33},"Point",[34,35],4.47917,51.9225,{"lat":35,"lon":34},[38],{"name":39,"role":19,"phone":20,"phoneExt":7,"email":21},"Charlène vd Zijden",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","Bas P. L. Wijnhoven","Principal Investigator","100430558","surgery-as-needed-for-oesophageal-cancer---2-100430558",false,"NCT04886635","Surgery As Needed for Oesophageal Cancer - 2","A Prospective Cohort Study on Active Surveillance After Neoadjuvant Chemoradiation for Oesophageal Cancer: SANO-2 Study","SANO-2","Inclusion Criteria:\n\n* Operable patients who are planned to undergo or who recently underwent neoadjuvant chemoradiotherapy according to CROSS followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophago-gastric junction\n* Age ≥18\n* Written, voluntary, informed consent.\n\nExclusion Criteria:\n\n* Non-FDG-avid tumour at baseline PET-CT scan\n* Initial treatment with endoscopic resection\n* Patients who underwent of who are planned to undergo definitive chemoradiotherapy\n* Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent.","ALL","18 Years",{"count":55,"type":56},360,"ESTIMATED","OBSERVATIONAL","A prospective cohort study on active surveillance after neoadjuvant chemoradiation for oesophageal cancer: SANO-2 study.",[60],"Cancer of Esophagus","2024-02-16",{"date":63,"type":64},"2024-02-20","ACTUAL",{"date":66,"type":64},"2021-03-09",{"date":68,"type":56},"2029-01-01",{"name":42,"class":6},1]