Nilsson, Magnus, Olafsdottir, Halla, Alexandersson von Doebeln, Gabriella, Villegas, Fernanda, Gagliardi, Giovanna, Hellstroem, Mats, Wang, Qiao-Li ORCID: 0000-0003-4152-7821, Johansson, Hemming, Gebski, Val ORCID: 0000-0001-8748-1844, Hedberg, Jakob, Klevebro, Fredrik, Markar, Sheraz, Smyth, Elizabeth, Lagergren, Pernilla, Al-Haidari, Ghazwan, Rekstad, Lars Cato, Aahlin, Eirik Kjus, Wallner, Bengt, Edholm, David, Johansson, Jan, Szabo, Eva, Reynolds, John V., Pramesh, C. S., Mummudi, Naveen, Joshi, Amit, Ferri, Lorenzo, Wong, Rebecca K. S., O'Callaghan, Chris, Lukovic, Jelena, Chan, Kelvin K. W., Leong, Trevor, Barbour, Andrew, Smithers, Mark, Li, Yin, Kang, Xiaozheng, Kong, Feng-Ming, Chao, Yin-Kai, Crosby, Tom, Bruns, Christiane, van Laarhoven, Hanneke, van Berge Henegouwen, Mark, van Hillegersberg, Richard, Rosati, Riccardo, Piessen, Guillaume, de Manzoni, Giovanni and Lordick, Florian (2022). 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. Front. Oncol., 12. LAUSANNE: FRONTIERS MEDIA SA. ISSN 2234-943X

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Abstract

Background: 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 post-surgical 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. Methods: 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Nilsson, MagnusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Olafsdottir, HallaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alexandersson von Doebeln, GabriellaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Villegas, FernandaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gagliardi, GiovannaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hellstroem, MatsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wang, Qiao-LiUNSPECIFIEDorcid.org/0000-0003-4152-7821UNSPECIFIED
Johansson, HemmingUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gebski, ValUNSPECIFIEDorcid.org/0000-0001-8748-1844UNSPECIFIED
Hedberg, JakobUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klevebro, FredrikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Markar, SherazUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Smyth, ElizabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lagergren, PernillaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Al-Haidari, GhazwanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rekstad, Lars CatoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aahlin, Eirik KjusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wallner, BengtUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Edholm, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Johansson, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Szabo, EvaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reynolds, John V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pramesh, C. S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mummudi, NaveenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Joshi, AmitUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ferri, LorenzoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wong, Rebecca K. S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
O'Callaghan, ChrisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lukovic, JelenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chan, Kelvin K. W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Leong, TrevorUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barbour, AndrewUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Smithers, MarkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Li, YinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kang, XiaozhengUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kong, Feng-MingUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chao, Yin-KaiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Crosby, TomUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bruns, ChristianeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Laarhoven, HannekeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Berge Henegouwen, MarkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Hillegersberg, RichardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rosati, RiccardoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Piessen, GuillaumeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Manzoni, GiovanniUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lordick, FlorianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-698776
DOI: 10.3389/fonc.2022.917961
Journal or Publication Title: Front. Oncol.
Volume: 12
Date: 2022
Publisher: FRONTIERS MEDIA SA
Place of Publication: LAUSANNE
ISSN: 2234-943X
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
QUALITY-OF-LIFE; PREOPERATIVE CHEMORADIOTHERAPY; CANCER; CHEMORADIATION; CONSENSUS; JUNCTION; COMPLICATIONS; EORTC; RTOGMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69877

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