Lund University Publications

@article{0d0ee151-2c38-4ca2-a45a-35e976da5553,
  abstract     = {{<p>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.</p><p>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.</p><p>Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04460352.</p>}},
  author       = {{Nilsson, Magnus and Olafsdottir, Halla and Alexandersson von Döbeln, Gabriella and Villegas, Fernanda and Gagliardi, Giovanna and Hellström, Mats and Wang, Qiao-Li and Johansson, Hemming and Gebski, Val and Hedberg, Jakob and Klevebro, Fredrik and Markar, Sheraz and Smyth, Elizabeth and Lagergren, Pernilla and Al-Haidari, Ghazwan and Rekstad, Lars Cato and Aahlin, Eirik Kjus and Wallner, Bengt and Edholm, David and Johansson, Jan and Szabo, Eva and Reynolds, John V and Pramesh, C S and Mummudi, Naveen and Joshi, Amit and Ferri, Lorenzo and Wong, Rebecca Ks and O'Callaghan, Chris and Lukovic, Jelena and Chan, Kelvin Kw and Leong, Trevor and Barbour, Andrew and Smithers, Mark and Li, Yin and Kang, Xiaozheng and Kong, Feng-Ming and Chao, Yin-Kai and Crosby, Tom and Bruns, Christiane and van Laarhoven, Hanneke and van Berge Henegouwen, Mark and van Hillegersberg, Richard and Rosati, Riccardo and Piessen, Guillaume and de Manzoni, Giovanni and Lordick, Florian}},
  issn         = {{2234-943X}},
  language     = {{eng}},
  publisher    = {{Frontiers Media S. A.}},
  series       = {{Frontiers in Oncology}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.3389/fonc.2022.917961}},
  doi          = {{10.3389/fonc.2022.917961}},
  volume       = {{12}},
  year         = {{2022}},
}