[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397840":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":67,"centralContacts":74,"locations":82,"responsibleParty":286,"collaborators":289,"id":295,"slug":296,"hasResults":297,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":297,"sex":303,"minAge":304,"maxAge":305,"enrollmentInfo":306,"targetDuration":30,"studyType":309,"phases":310,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":85,"whyStopped":30,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},{"fullName":5,"class":6},"Karolinska University Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Control arm (A)","ACTIVE_COMPARATOR","Neoadjuvant chemoradiotherapy followed by esophagectomy.\n\nRadiotherapy: 1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.\n\nChemotherapy: Carboplatin AUC 2 + Paclitaxel 50mg\u002Fm2 weekly x 5 (day 1, 8, 15, 22, 29), starting on the first day of radiotherapy.\n\nEsophagectomy: Within 8 weeks of termination of chemoradiotherapy,",[13,14,15],"Radiation: Neoadjuvant radiotherapy (arm A)","Drug: Carboplatin, paclitaxel","Procedure: Esophagectomy",{"label":17,"type":18,"description":19,"interventionNames":20},"Experimental arm (B)","EXPERIMENTAL","Definitive chemoradiotherapy followed by surveillance, and esophagectomy only in case of residual or recurrent locoregional cancer.\n\nRadiotherapy: Two alternative schemes:\n\n1. 1.8 Gy fractions five days per week in 28 fractions to a total dose of 50.4 Gy.\n2. 2.0 Gy fractions five days per week in 25 fractions to a total dose of 50 Gy.\n\nChemotherapy: Three alternative regimens:\n\n1\\. Platin-Taxane Regimen: Carboplatin AUC 2 + Paclitaxel 50mg\u002Fm2 on day 1 weekly during the full course of radiotherapy.\n\n2a. Platinum-Fluoropyrimidine Regimen: Cisplatin 75mg\u002Fm2 weeks 1 and 5 + 5-fluorouracil 1000 mg\u002Fm2\u002Fday by continuous infusion weeks 1 and 5.\n\n2b. FOLFOX: Oxaliplatin 85 mg\u002Fm2, calcium folinate 200 mg\u002Fm2 and 5-fluorouracil 400 mg\u002Fm2 weeks 1, 3 and 5 + 5-fluorouracil 800 mg\u002Fm2 by continuous infusion weeks 1, 3 and 5.",[21,14,22,23,15],"Radiation: Neoadjuvant radiotherapy (arm B)","Drug: Cisplatin, paclitaxel","Drug: Oxaliplatin, calcium folinate, 5-fluorouracil",[25,31,38,43,47,52,58,64],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"RADIATION","Neoadjuvant radiotherapy (arm A)","1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Carboplatin, paclitaxel","Carboplatin AUC 2 + Paclitaxel 50mg\u002Fm2 weekly x 5 (day 1, 8, 15, 22, 29), starting same day as radiotherapy",[9],[37],"Neoadjuvant chemotherapy",{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":30},"PROCEDURE","Esophagectomy","Esophagectomy performed within 8 weeks after termination of chemoradiotherapy",[9],{"type":26,"name":44,"description":45,"armGroupLabels":46,"otherNames":30},"Neoadjuvant radiotherapy (arm B)","Two alternative schemes:\n\n1. 1.8 Gy fractions five days per week in 28 fractions to a total dose of 50.4 Gy.\n2. 2.0 Gy fractions five days per week in 25 fractions to a total dose of 50 Gy.",[17],{"type":32,"name":33,"description":48,"armGroupLabels":49,"otherNames":50},"Carboplatin AUC 2 + Paclitaxel 50mg\u002Fm2 on day 1 weekly during the full course of radiotherapy (5 weeks or 6 weeks, depending on the radiotherapy regimen used).",[17],[51],"Neoadjuvant Platin-Taxane Regimen (alternative 1)",{"type":32,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Cisplatin, paclitaxel","Cisplatin 75mg\u002Fm2 on the first day of weeks 1 and 5 + 5-fluorouracil 1000 mg\u002Fm2\u002Fday by continuous infusion on the first four days of weeks 1 and 5.",[17],[57],"Platinum-Fluoropyrimidine Regimens (alternative 2a)",{"type":32,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Oxaliplatin, calcium folinate, 5-fluorouracil","FOLFOX: Oxaliplatin 85 mg\u002Fm2, calcium folinate 200 mg\u002Fm2 and 5-fluorouracil 400 mg\u002Fm2 on the first days of weeks 1, 3 and 5 + 5-fluorouracil 800 mg\u002Fm2 by continuous infusion on the first two days of weeks 1, 3 and 5.",[17],[63],"Platinum-Fluoropyrimidine Regimens (alternative 2b)",{"type":39,"name":40,"description":65,"armGroupLabels":66,"otherNames":30},"Esophagectomy only in case of residual or recurrent locoregional cancer.",[17],[68,71],{"name":69,"affiliation":5,"role":70},"Magnus Nilsson, MD, PhD","STUDY_CHAIR",{"name":72,"affiliation":73,"role":70},"Florian Lordick, MD, PhD","Leipzig University Medical Center",[75,79],{"name":69,"role":76,"phone":77,"phoneExt":30,"email":78},"CONTACT","+46-707-375186","magnus.nilsson@ki.se",{"name":80,"role":76,"phone":30,"phoneExt":30,"email":81},"Mats Hellström","mats.hellstrom@regionstockholm.se",[83,103,126,142,158,172,189,206,220,237,254,268],{"facility":84,"status":85,"city":86,"state":87,"zip":30,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"McGill University Health Centre","RECRUITING","Montreal","Quebec","Canada","CA",{"type":91,"coordinates":92},"Point",[93,94],-73.58781,45.50884,{"lat":94,"lon":93},[97,100],{"name":98,"role":76,"phone":30,"phoneExt":30,"email":99},"Mehrnoush Dehgani, PhD","mehrnoush.dehghani@muhc.mcgill.ca",{"name":101,"role":102,"phone":30,"phoneExt":30,"email":30},"Lorenzo Ferri, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":104,"status":85,"city":105,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Cancer Clinical Trials Unit (CCTU) at St. James's Hospital","Dublin","D08 NHY1","Ireland","IE",{"type":91,"coordinates":110},[111,112],-6.24889,53.33306,{"lat":112,"lon":111},[115,119,121,124],{"name":116,"role":76,"phone":117,"phoneExt":30,"email":118},"Ingrid Kiernan","+353 1 4103754","cancerclinicaltrials@stjames.ie",{"name":120,"role":102,"phone":30,"phoneExt":30,"email":30},"John Reynolds, Prof",{"name":122,"role":123,"phone":30,"phoneExt":30,"email":30},"Grainne O'Kane, Dr","SUB_INVESTIGATOR",{"name":125,"role":123,"phone":30,"phoneExt":30,"email":30},"Moya Cunningham, Dr",{"facility":127,"status":85,"city":128,"state":30,"zip":30,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Oslo universitetssykehus","Oslo","Norway","NO",{"type":91,"coordinates":132},[133,134],10.74609,59.91273,{"lat":134,"lon":133},[137,140],{"name":138,"role":76,"phone":30,"phoneExt":30,"email":139},"Janne Christoffersen, RN","jannec@ous-hf.no",{"name":141,"role":102,"phone":30,"phoneExt":30,"email":30},"Ghazwan Al-Haidari, MD, PhD",{"facility":143,"status":85,"city":144,"state":30,"zip":30,"country":129,"countryCode":130,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Universitetssykehuset Nord-Norge","Tromsø",{"type":91,"coordinates":146},[147,148],18.95508,69.6489,{"lat":148,"lon":147},[151,154,157],{"name":152,"role":76,"phone":30,"phoneExt":30,"email":153},"Eirik Kjus Aahlin, MD, PhD","eirik.kjus.aahlin@unn.no",{"name":155,"role":76,"phone":30,"phoneExt":30,"email":156},"Kristin Woll, RN","kristin.woll@unn.no",{"name":152,"role":102,"phone":30,"phoneExt":30,"email":30},{"facility":159,"status":85,"city":160,"state":30,"zip":30,"country":129,"countryCode":130,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"St Olavs Hospital","Trondheim",{"type":91,"coordinates":162},[163,164],10.39506,63.43049,{"lat":164,"lon":163},[167,170],{"name":168,"role":76,"phone":30,"phoneExt":30,"email":169},"Marte Romundstad, RN","marte.romunstad@stolav.no",{"name":171,"role":102,"phone":30,"phoneExt":30,"email":30},"Lars Cato Rekstad, MD, PhD",{"facility":173,"status":85,"city":174,"state":30,"zip":30,"country":175,"countryCode":176,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Linköpings universitetssjukhus","Linköping","Sweden","SE",{"type":91,"coordinates":178},[179,180],15.62157,58.41086,{"lat":180,"lon":179},[183,186],{"name":184,"role":76,"phone":30,"phoneExt":30,"email":185},"David Edholm, MD","david.edholm@regionostergotland.se",{"name":187,"role":76,"phone":30,"phoneExt":30,"email":188},"Anna Lindhoff Larsson, RN","anna.lindhoff.larsson@regionostergotland.se",{"facility":190,"status":85,"city":191,"state":30,"zip":30,"country":175,"countryCode":176,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Skånes universitetssjukhus","Lund",{"type":91,"coordinates":193},[194,195],13.19321,55.70584,{"lat":195,"lon":194},[198,201,204],{"name":199,"role":76,"phone":30,"phoneExt":30,"email":200},"Monika Meszaros, RN","monika.meszaros@skane.se",{"name":202,"role":76,"phone":30,"phoneExt":30,"email":203},"Marit Bakos, RN","marit.bakos@skane.se",{"name":205,"role":102,"phone":30,"phoneExt":30,"email":30},"Jan Johansson, MD, PhD",{"facility":207,"status":85,"city":208,"state":30,"zip":30,"country":175,"countryCode":176,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Örebro universitetssjukhus","Örebro",{"type":91,"coordinates":210},[211,212],15.2066,59.27412,{"lat":212,"lon":211},[215,218],{"name":216,"role":76,"phone":30,"phoneExt":30,"email":217},"Linnea Sundström, RN","linnea.sundstrom@regionorebrolan.se",{"name":219,"role":102,"phone":30,"phoneExt":30,"email":30},"Eva Szabo, MD, PhD",{"facility":5,"status":85,"city":221,"state":30,"zip":30,"country":175,"countryCode":176,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Stockholm",{"type":91,"coordinates":223},[224,225],18.06871,59.32938,{"lat":225,"lon":224},[228,231,234,235],{"name":229,"role":76,"phone":30,"phoneExt":30,"email":230},"Berit Sunde, RN, PhD","berit.sunde@ki.se",{"name":232,"role":76,"phone":30,"phoneExt":30,"email":233},"Maria Lampi, RN","maria.lampi@regionstockholm.se",{"name":69,"role":102,"phone":30,"phoneExt":30,"email":30},{"name":236,"role":123,"phone":30,"phoneExt":30,"email":30},"Gabriella Alexandersson von Döbeln, MD, PhD",{"facility":238,"status":85,"city":239,"state":30,"zip":30,"country":175,"countryCode":176,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Norrlands universitetssjukhus","Umeå",{"type":91,"coordinates":241},[242,243],20.25972,63.82842,{"lat":243,"lon":242},[246,249,252],{"name":247,"role":76,"phone":30,"phoneExt":30,"email":248},"Birgitta Orrvik Olsson, RN","birgitta.orrvikolsson@regionvasterbotten.se",{"name":250,"role":76,"phone":30,"phoneExt":30,"email":251},"Agneta Karhu, RN","agneta.karhu@regionvasterbotten.se",{"name":253,"role":102,"phone":30,"phoneExt":30,"email":30},"Bengt Wallner, MD, PhD",{"facility":255,"status":85,"city":256,"state":30,"zip":30,"country":175,"countryCode":176,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Akademiska sjukhuset","Uppsala",{"type":91,"coordinates":258},[259,260],17.63889,59.85882,{"lat":260,"lon":259},[263,266],{"name":264,"role":76,"phone":30,"phoneExt":30,"email":265},"Lena Ekfjord, RN","lena.ekfjord@akademiska.se",{"name":267,"role":102,"phone":30,"phoneExt":30,"email":30},"Jakob Hedberg, MD, PhD",{"facility":269,"status":85,"city":270,"state":30,"zip":30,"country":271,"countryCode":272,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Chang Gung Memorial Hospital","Linkou District","Taiwan","TW",{"type":91,"coordinates":274},[275,276],121.39348,25.07777,{"lat":276,"lon":275},[279,282,285],{"name":280,"role":76,"phone":30,"phoneExt":30,"email":281},"Yinkai Chao, MD","chaoyk@gmail.com",{"name":283,"role":76,"phone":30,"phoneExt":30,"email":284},"Tzuyi Yang","larryboy0945@cgmh.org.tw",{"name":280,"role":102,"phone":30,"phoneExt":30,"email":30},{"type":102,"investigatorFullName":287,"investigatorTitle":288,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Magnus Nilsson","Professor",[290,292],{"name":291,"class":6},"University of Leipzig",{"name":293,"class":294},"The Swedish Research Council","OTHER_GOV","100397840","phase-3-chemoradiotherapy-followed-by-planned-surgery-or-by-surveillance-and-surgery-only-when-needed-for-oesophageal-cancer-100397840",false,"NCT04460352","Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer","NEoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed (NEEDS Trial)","NEEDS","Inclusion Criteria:\n\n* Histopathologically confirmed SCC of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0, according to current (8th) version of of the AJCC TNM classification.\n* Technically resectable disease according to the local multidisciplinary team conference (MDT)\u002Ftumor board.\n* Performance status ECOG 0-1.\n* Adequate organ function.\n* Women of childbearing potential (WOCBP\\*) must have a negative serum or urine pregnancy test.\n* Patients of childbearing\u002Freproductive potential should use highly effective method of birth control measures during the study treatment period and for at least five months after the last study treatment.\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n* Before patient registration\u002Frandomization, written informed consent must be given according to ICH\u002FGCP\u002FGDPR and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* M1 according to current (8th) version of of the AJCC TNM classification.\n* cT4b according to current (8th) version of of the AJCC TNM classification.\n* Primary tumor not resectable without laryngectomy.\n* Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for multimodality treatment with chemoradiotherapy followed by esophagectomy.\n* Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy.\n* Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.\n* Prior or concomitant treatment with radiotherapy or chemoradiotherapy with potential overlap of radiotherapy fields.\n* Known uncontrollable hypersensitivity to the components of the chemotherapeutic agents used in the trial regimens.\n* Inability to fully understand and digest study patient information or to comply with study instructions due to language difficulty or cognitive failure such as dementia or severe psychiatric disorder.\n\n(Criteria slightly shortened)","ALL","18 Years","80 Years",{"count":307,"type":308},1020,"ESTIMATED","INTERVENTIONAL",[311],"PHASE3","NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the first co-primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy. A second co-primary endpoint is global health related quality of life (HRQOL) one year after randomisation. A third co-primary endpoint is eating restictions one year after randomisation.\n\nThe aim is to compare outcomes after neoadjuvant chemoradiotherapy with subsequent esophagectomy to definitive chemoradiotherapy with surveillance and salvage esophagectomy as needed in patients with resectable locally advanced squamous cell carcinoma (SCC) of the esophagus, with the aim to provide generalisable guidance for future clinical practice.",[314],"Esophageal Squamous Cell Carcinoma",[316,317],"Neoadjuvant chemoradiotherapy","Definitive chemoradiotherapy with salvage surgery as needed","2025-03-04",{"date":320,"type":321},"2025-03-06","ACTUAL",{"date":323,"type":321},"2020-11-27",{"date":325,"type":308},"2031-12-31",{"name":5,"class":6},12]