Evidence map›Paper›PMID 35912196›Full record

ArticleFrontiers in oncology2022

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.

Magnus Nilsson, Halla Olafsdottir, Gabriella Alexandersson von Döbeln, Fernanda Villegas, Giovanna Gagliardi, Mats Hellström, Qiao-Li Wang, Hemming Johansson, Val Gebski, Jakob Hedberg and 36 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04460352 (NEoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
6.1field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04460352 phase3recruitingnot on this map

NEoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed (NEEDS Trial)

TypeinterventionalSponsorKarolinska University HospitalRan2020 to 2031Enrolled1,020ConditionsEsophageal Squamous Cell CarcinomaArmsNeoadjuvant radiotherapy (arm A), Carboplatin, paclitaxel, Esophagectomy, Neoadjuvant radiotherapy (arm B), Cisplatin, paclitaxel
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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  19. Overall survival after definitive chemoradiotherapy for patients with esophageal cancer: a retrospective cohort study.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

46 authors at 20 institutions in 12 countries.

Magnus NilssonDivision of Surgery, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Halla OlafsdottirDivision of Surgery, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Gabriella Alexandersson von DöbelnDivision of Surgery, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Fernanda VillegasSection of Radiotherapy Physics and Engineering, Department of Medical Radiation Physics and Nuclear Medicine, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden.
Giovanna GagliardiSection of Radiotherapy Physics and Engineering, Department of Medical Radiation Physics and Nuclear Medicine, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden.
Mats HellströmCenter for Clinical Cancer Studies, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden.
Qiao-Li WangDivision of Surgery, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Hemming JohanssonCenter for Clinical Cancer Studies, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden.
Val GebskiNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Jakob HedbergDepartment of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
Fredrik KlevebroDivision of Surgery, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Sheraz MarkarNuffield Department of Surgery, University of Oxford, Oxford, United Kingdom.
Elizabeth SmythDepartment of Oncology, Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, United Kingdom.
Pernilla LagergrenDepartment of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Ghazwan Al-HaidariDepartment of Oncology, Oslo University Hospital, Oslo, Norway.
Lars Cato RekstadDepartment of Gastrointestinal Surgery, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
Eirik Kjus AahlinDepartment of GI and HPB Surgery, University Hospital of Northern Norway, Tromsø, Norway.
Bengt WallnerDepartment of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden.
David EdholmDepartment of Surgery, Linköping University Hospital, Linköping, Sweden.
Jan JohanssonDepartment of Surgery, Skåne University Hospital, Lund, Sweden.
Eva SzaboDepartment of Surgery, University Hospital of Örebro, Örebro, Sweden.
John V ReynoldsDepartment of Surgery, Trinity St James's Cancer Institute, Dublin, Ireland.
C S PrameshTata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.
Naveen MummudiTata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.
Amit JoshiTata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.
Lorenzo FerriDepartment of Thoracic Surgery, McGill University Health Centre, Montreal, QC, Canada.
Rebecca Ks WongRadiation Medicine Program, Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada.
Chris O'CallaghanCanadian Cancer Trials Group, Kingston, ON, Canada.
Jelena LukovicRadiation Medicine Program, Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada.
Kelvin Kw ChanSunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Trevor LeongSir Peter MacCallum Department of Oncology, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia.
Andrew BarbourAcademy of Surgery, University of Queensland, Princess Alexandra Hospital, Brisbane, QLD, Australia.
Mark SmithersAcademy of Surgery, University of Queensland, Princess Alexandra Hospital, Brisbane, QLD, Australia.
Yin LiDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Xiaozheng KangDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Feng-Ming KongThoracic Oncology Center, HKU Shenzhen Hospital, Hong Kong University Li Ka Shing Medical School, Shenzhen, China.
Yin-Kai ChaoDepartment of thoracic surgery, Chang Gung Memorial Hospital-Linkou, Chang Gung University, Taoyuan, Taiwan.
Tom CrosbyDepartment of Clinical Oncology, Velindre Cancer Centre, Cardiff, United Kingdom.
Christiane BrunsDepartment of General, Visceral and Cancer Surgery, University Hospital of Cologne, Cologne, Germany.
Hanneke van LaarhovenDepartment of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Amsterdam, Netherlands.
Mark van Berge HenegouwenDepartment of Surgery, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.
Richard van HillegersbergDepartmentof Surgery, University Medical Center Utrecht, Utrecht, Netherlands.
Riccardo RosatiDepartment of Gastrointestinal Surgery, San Rafaele Hospital, Vita Salute University, Milan, Italy.
Guillaume PiessenUniv. Lille, CNRS, Inserm, CHU Lille, UMR9020-U1277 - CANTHER - Cancer Heterogeneity Plasticity and Resistance to Therapies, F-59000 Lille, France.
Giovanni de ManzoniUpper GI Surgery Division, University of Verona, Verona, Italy.
Florian LordickUniversity Cancer Center Leipzig, Leipzig University Medical Center, Leipzig, Germany.
Karolinska Institutet · SEKarolinska University Hospital · SEHomi Bhabha National Institute · INAmsterdam University Medical Centers · NLChinese Academy of Medical Sciences & Peking Union Medical College · CNPrincess Alexandra Hospital · AUCambridge University Hospitals NHS Foundation Trust · GBHealth Sciences Centre · CALeipzig University · DELinköping University Hospital · SELinkou Chang Gung Memorial Hospital · TWMcGill University Health Centre · CAÖrebro University Hospital · SEOslo University Hospital · NOPrincess Margaret Cancer Centre · CASkåne University Hospital · SESt Olav's University Hospital · NOThe University of Melbourne · AUThe University of Sydney · AUUmeå University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04460352.

Indexed as

definitive chemoradiotherapyesophageal squamous cell carcinomalocoregional surveillanceneoadjuvant chemoradiotherapysalvage esophagectomy

Identifiers

PMID35912196
PMCPMC9326032
OpenAlexW4285087994

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.