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dc.contributor.authorNilsson, Magnus
dc.contributor.authorOlafsdottir, Halla
dc.contributor.authorAlexandersson von Döbeln, Gabriella
dc.contributor.authorVillegas, Fernanda
dc.contributor.authorGagliardi, Giovanna
dc.contributor.authorHellström, Mats
dc.contributor.authorWang, Qiao-Li
dc.contributor.authorJohansson, Hemming
dc.contributor.authorGebski, Val
dc.contributor.authorHedberg, Jakob
dc.contributor.authorKlevebro, Fredrik
dc.contributor.authorMarkar, Sheraz
dc.contributor.authorSmyth, Elizabeth
dc.contributor.authorLagergren, Pernilla
dc.contributor.authorAl-Haidari, Ghazwan Ahmed Dhia Eldin
dc.contributor.authorRekstad, Lars Cato
dc.contributor.authorAahlin, Eirik Kjus
dc.contributor.authorWallner, Bengt
dc.contributor.authorEdholm, David
dc.contributor.authorJohansson, Jan
dc.contributor.authorSzabo, Eva
dc.contributor.authorReynolds, John V.
dc.contributor.authorPramesh, C.S.
dc.contributor.authorMummudi, Naveen
dc.contributor.authorJoshi, Amit
dc.contributor.authorFerri, Lorenzo
dc.contributor.authorWong, Rebecca KS
dc.contributor.authorO’Callaghan, Chris
dc.contributor.authorLukovic, Jelena
dc.contributor.authorChan, Kelvin KW
dc.contributor.authorLeong, Trevor
dc.contributor.authorBarbour, Andrew
dc.contributor.authorSmithers, Mark
dc.contributor.authorLi, Yin
dc.contributor.authorKang, Xiaozheng
dc.contributor.authorKong, Feng-Ming
dc.contributor.authorChao, Yin-Kai
dc.contributor.authorCrosby, Tom
dc.contributor.authorBruns, Christiane
dc.contributor.authorvan Laarhoven, Hanneke
dc.contributor.authorvan Berge Henegouwen, Mark
dc.contributor.authorvan Hillegersberg, Richard
dc.contributor.authorRosati, Riccardo
dc.contributor.authorPiessen, Guillaume
dc.contributor.authorde Manzoni, Giovanni
dc.contributor.authorLordick, Florian
dc.date.accessioned2022-11-22T13:31:05Z
dc.date.available2022-11-22T13:31:05Z
dc.date.issued2022-07-13
dc.description.abstract<b><p>Background:</b> The globally dominant treatment with curative intent for locally advanced esophageal squamous cell carcinoma (ESCC) is neoadjuvant chemoradiotherapy (nCRT) with subsequent esophagectomy. This multimodal treatment leads to around 60% overall 5-year survival, yet with impaired postsurgical quality of life. Observational studies indicate that curatively intended chemoradiotherapy, so-called definitive chemoradiotherapy (dCRT) followed by surveillance of the primary tumor site and regional lymph node stations and surgery only when needed to ensure local tumor control, may lead to similar survival as nCRT with surgery, but with considerably less impairment of quality of life. This trial aims to demonstrate that dCRT, with selectively performed salvage esophagectomy only when needed to achieve locoregional tumor control, is non-inferior regarding overall survival, and superior regarding health-related quality of life (HRQOL), compared to nCRT followed by mandatory surgery, in patients with operable, locally advanced ESCC. <b><p>Methods:</b> This is a pragmatic open-label, randomized controlled phase III, multicenter trial with non-inferiority design with regard to the primary endpoint overall survival and a superiority hypothesis for the experimental intervention dCRT with regard to the main secondary endpoint global HRQOL one year after randomization. The control intervention is nCRT followed by preplanned surgery and the experimental intervention is dCRT followed by surveillance and salvage esophagectomy only when needed to secure local tumor control. A target sample size of 1200 randomized patients is planned in order to reach 462 events (deaths) during follow-up.en_US
dc.identifier.citationNilsson, Olafsdottir, Alexandersson von Döbeln, Villegas, Gagliardi, Hellström, Wang, Johansson, Gebski, Hedberg, Klevebro, Markar, Smyth, Lagergren, Al-Haidari, Rekstad, Aahlin, Wallner, Edholm, Johansson, Szabo, Reynolds, Pramesh, Mummudi, Joshi, Ferri, Wong, O’Callaghan, Lukovic, Chan, Leong, Barbour, Smithers, Li, Kang, Kong, Chao, Crosby, Bruns, van Laarhoven, van Berge Henegouwen, van Hillegersberg, Rosati, Piessen, de Manzoni, Lordick. Neoadjuvant Chemoradiotherapy and Surgery for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed: The Study Protocol for the Randomized Controlled NEEDS Trial. Frontiers in Oncology. 2022;12en_US
dc.identifier.cristinIDFRIDAID 2060781
dc.identifier.doi10.3389/fonc.2022.917961
dc.identifier.issn2234-943X
dc.identifier.urihttps://hdl.handle.net/10037/27472
dc.language.isoengen_US
dc.publisherFrontiers Mediaen_US
dc.relation.journalFrontiers in Oncology
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2022 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)en_US
dc.titleNeoadjuvant Chemoradiotherapy and Surgery for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed: The Study Protocol for the Randomized Controlled NEEDS Trialen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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Attribution 4.0 International (CC BY 4.0)
Med mindre det står noe annet, er denne innførselens lisens beskrevet som Attribution 4.0 International (CC BY 4.0)