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

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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

Nilsson, Magnus (författare): Karolinska Institutet,Karolinska Inst, Dept Clin Sci Intervent & Technol, Div Surg, Stockholm, Sweden.;Karolinska Univ Hosp, Karolinska Comprehens Canc Ctr, Dept Upper Abdominal Dis, Stockholm, Sweden.

Olafsdottir, Halla (författare): Karolinska Institutet,Karolinska Inst, Dept Clin Sci Intervent & Technol, Div Surg, Stockholm, Sweden.;Karolinska Univ Hosp, Thorac Oncol Ctr, Karolinska Comprehens Canc Ctr, Stockholm, Sweden.

Alexandersson von Döbeln, Gabriella (författare): Karolinska Institutet,Karolinska Inst, Dept Clin Sci Intervent & Technol, Div Surg, Stockholm, Sweden.;Karolinska Univ Hosp, Thorac Oncol Ctr, Karolinska Comprehens Canc Ctr, Stockholm, Sweden.

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Villegas, Fernanda (författare): Section of Radiotherapy Physics and Engineering, Department of Medical Radiation Physics and Nuclear Medicine, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden,Karolinska Univ Hosp, Karolinska Comprehens Canc Ctr, Dept Med Radiat Phys & Nucl Med, Sect Radiotherapy Phys & Engn, Stockholm, Sweden.

Gagliardi, Giovanna (författare): Section of Radiotherapy Physics and Engineering, Department of Medical Radiation Physics and Nuclear Medicine, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden,Karolinska Univ Hosp, Karolinska Comprehens Canc Ctr, Dept Med Radiat Phys & Nucl Med, Sect Radiotherapy Phys & Engn, Stockholm, Sweden.

Hellström, Mats (författare): Center for Clinical Cancer Studies, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden,Karolinska Univ Hosp, Ctr Clin Canc Studies, Karolinska Comprehens Canc Ctr, Stockholm, Sweden.

Wang, Qiao-Li (författare): Karolinska Institutet,Karolinska Inst, Dept Clin Sci Intervent & Technol, Div Surg, Stockholm, Sweden.

Johansson, Hemming (författare): Center for Clinical Cancer Studies, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden; Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden,Karolinska Univ Hosp, Ctr Clin Canc Studies, Karolinska Comprehens Canc Ctr, Stockholm, Sweden.;Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden.

Gebski, Val (författare): NHMRC Clinical, Trials Centre, University of Sydney, NSW, Sydney, Australia,Univ Sydney, NHMRC Clin Trials Ctr, Sydney, NSW, Australia.

Hedberg, Jakob, 1972- (författare): Uppsala universitet,Gastrointestinalkirurgi,Uppsala Univ Hosp, Sweden

Klevebro, Fredrik (författare): Karolinska Institutet,Karolinska Inst, Dept Clin Sci Intervent & Technol, Div Surg, Stockholm, Sweden.;Karolinska Univ Hosp, Karolinska Comprehens Canc Ctr, Dept Upper Abdominal Dis, Stockholm, Sweden.

Markar, Sheraz (författare): Nuffield Department of Surgery, University of Oxford, Oxford, United Kingdom; Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden,Univ Oxford, Nuffield Dept Surg, Oxford, England.;Karolinska Inst, Dept Mol Med & Surg, Stockholm, Sweden.

Smyth, Elizabeth (författare): Department of Oncology, Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, United Kingdom,Cambridge Univ Hosp Natl Hlth Serv Fdn Trust, Dept Oncol, Cambridge, England.

Lagergren, Pernilla (författare): Karolinska Institutet,Karolinska Inst, Dept Mol Med & Surg, Stockholm, Sweden.;Imperial Coll London, Dept Surg & Canc, London, England.

Al-Haidari, Ghazwan (författare): Department of Oncology, Oslo University Hospital, Oslo, Norway,Oslo Univ Hosp, Dept Oncol, Oslo, Norway.

Rekstad, Lars Cato (författare): Department of Gastrointestinal Surgery, St. Olav’s Hospital, Trondheim University Hospital, Trondheim, Norway,Trondheim Reg & Univ Hosp, St Olavs Hosp, Dept Gastrointestinal Surg, Trondheim, Norway.

Aahlin, Eirik Kjus (författare): Department of GI and HPB Surgery, University Hospital of Northern Norway, Tromsø, Norway,Univ Hosp Northern Norway, Dept GI & HPB Surg, Tromso, Norway.

Wallner, Bengt, 1962- (författare): Umeå universitet,Kirurgi,Umeå Univ, Dept Surg & Perioperat Sci, Surg, Umeå, Sweden.

Edholm, David (författare): Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Kirurgiska kliniken US

Johansson, Jan (författare): Department of Surgery, Skåne University Hospital, Lund, Sweden,Skane Univ Hosp, Dept Surg, Lund, Sweden.

Szabo, Eva (författare): Department of Surgery, University Hospital of Örebro, Örebro, Sweden,Univ Hosp Örebro, Dept Surg, Örebro, Sweden.

Reynolds, John V. (författare): Department of Surgery, Trinity St James’s Cancer Institute, Dublin, Ireland,Trinity St Jamess Canc Inst, Dept Surg, Dublin, Ireland.

Pramesh, C.S. (författare): Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India,Homi Bhabha Natl Inst, Tata Mem Ctr, Mumbai, India.

Mummudi, Naveen (författare): Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India,Homi Bhabha Natl Inst, Tata Mem Ctr, Mumbai, India.

Joshi, Amit (författare): Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India,Homi Bhabha Natl Inst, Tata Mem Ctr, Mumbai, India.

Ferri, Lorenzo (författare): Department of Thoracic Surgery, McGill University Health Centre, QC, Montreal, Canada,McGill Univ Hlth Ctr, Dept Thorac Surg, Montreal, PQ, Canada.

Wong, Rebecca K.S. (författare): Radiation Medicine Program, Princess Margaret Cancer Center, University Health Network, ON, Toronto, Canada; Department of Radiation Oncology, University of Toronto, ON, Toronto, Canada,Univ Hlth Network, Princess Margaret Canc Ctr, Radiat Med Program, Toronto, ON, Canada.;Univ Toronto, Dept Radiat Oncol, Toronto, ON, Canada.

O’Callaghan, Chris (författare): Canadian Cancer Trials Group, ON, Kingston, Canada

Lukovic, Jelena (författare): Radiation Medicine Program, Princess Margaret Cancer Center, University Health Network, ON, Toronto, Canada; Department of Radiation Oncology, University of Toronto, ON, Toronto, Canada,Univ Hlth Network, Princess Margaret Canc Ctr, Radiat Med Program, Toronto, ON, Canada.;Univ Toronto, Dept Radiat Oncol, Toronto, ON, Canada.

Chan, Kelvin K.W. (författare): Sunnybrook Health Sciences Centre, University of Toronto, ON, Toronto, Canada,Univ Toronto, Sunnybrook Hlth Sci Ctr, Toronto, ON, Canada.

Leong, Trevor (författare): Sir Peter MacCallum, Department of Oncology, Peter MacCallum Cancer Centre, University of Melbourne, VIC, Melbourne, Australia,Univ Melbourne, Peter MacCallum Canc Ctr, Sir Peter MacCallum Dept Oncol, Melbourne, Vic, Australia.

Barbour, Andrew (författare): Academy of Surgery, University of Queensland, Princess Alexandra Hospital, QLD, Brisbane, Australia,Univ Queensland, Princess Alexandra Hosp, Acad Surg, Brisbane, Qld, Australia.

Smithers, Mark (författare): Academy of Surgery, University of Queensland, Princess Alexandra Hospital, QLD, Brisbane, Australia,Univ Queensland, Princess Alexandra Hosp, Acad Surg, Brisbane, Qld, Australia.

Li, Yin (författare): Department 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,Chinese Acad Med Sci & Peking Union Med Coll, Canc Canc Hosp, Dept Thorac Surg, Natl Canc Ctr,Natl Clin Res Ctr Canc,Canc Hosp, Beijing, Peoples R China.

Kang, Xiaozheng (författare): Department 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,Chinese Acad Med Sci & Peking Union Med Coll, Canc Canc Hosp, Dept Thorac Surg, Natl Canc Ctr,Natl Clin Res Ctr Canc,Canc Hosp, Beijing, Peoples R China.

Kong, Feng-Ming (författare): Thoracic Oncology Center, HKU Shenzhen Hospital, Hong Kong University Li Ka Shing Medical School, Shenzhen, China,Hong Kong Univ Li Ka Shing Med Sch, HKU Shenzhen Hosp, Thorac Oncol Ctr, Shenzhen, Peoples R China.

Chao, Yin-Kai (författare): Department of thoracic surgery, Chang Gung Memorial Hospital-Linkou, Chang Gung University, Taoyuan, Taiwan,Chang Gung Univ, Chang Gung Mem Hosp Linkou, Dept thorac Surg, Taoyuan, Taiwan.

Crosby, Tom (författare): Department of Clinical Oncology, Velindre Cancer Centre, Cardiff, United Kingdom,Velindre Canc Ctr, Dept Clin Oncol, Cardiff, Wales.

Bruns, Christiane (författare): Department of General, Visceral and Cancer Surgery, University Hospital of Cologne, Cologne, Germany,Univ Hosp Cologne, Dept Gen Visceral & Canc Surg, Cologne, Germany.

van Laarhoven, Hanneke (författare): Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Amsterdam, Netherlands,Amsterdam Univ Med Ctr, Canc Ctr Amsterdam, Dept Med Oncol, Amsterdam, Netherlands.

van Berge Henegouwen, Mark (författare): Department of Surgery, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands,Amsterdam Univ Med Ctr, Univ Amsterdam, Canc Ctr Amsterdam, Dept Surg, Amsterdam, Netherlands.

van Hillegersberg, Richard (författare): Departmentof Surgery, University Medical Center Utrecht, Utrecht, Netherlands,Univ Med Ctr Utrecht, Dept Surg, Utrecht, Netherlands.

Rosati, Riccardo (författare): Department of Gastrointestinal Surgery, San Rafaele Hospital, Vita Salute University, Milan, Italy,Univ Vita Salute San Raffaele, San Rafaele Hosp, Dept Gastrointestinal Surg, Milan, Italy.

Piessen, Guillaume (författare): Univ. Lille, CNRS, CHU Lille, UMR9020-U1277 - CANTHER – Cancer Heterogeneity Plasticity and Resistance to Therapies, Inserm, Lille, France,Univ Lille, CNRS, Inserm, CHU Lille,UMR9020 U1277 CANTHER Canc Heterogene Pl, F-59000 Lille, France.

de Manzoni, Giovanni (författare): Upper GI Surgery Division, University of Verona, Verona, Italy,Univ Verona, Upper GI Surg Div, Verona, Italy.

Lordick, Florian (författare): University Cancer Center Leipzig, Leipzig University Medical Center, Leipzig, Germany,Leipzig Univ Med Ctr, Univ Canc Ctr Leipzig, Leipzig, Germany.

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Karolinska Institutet Karolinska Inst, Dept Clin Sci Intervent & Technol, Div Surg, Stockholm, Sweden;Karolinska Univ Hosp, Karolinska Comprehens Canc Ctr, Dept Upper Abdominal Dis, Stockholm, Sweden. (creator_code:org_t)

2022-07-13
2022
Engelska.
Ingår i: Frontiers in Oncology. - : Frontiers Media S.A.. - 2234-943X. ; 12

Relaterad länk:: https://doi.org/10.3...; visa fler...; https://umu.diva-por... (primary) (Raw object); https://uu.diva-port... (primary) (Raw object); https://liu.diva-por... (primary) (Raw object); https://urn.kb.se/re...; https://doi.org/10.3...; http://kipublication...; https://urn.kb.se/re...; https://urn.kb.se/re...; visa färre...

Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

Stäng

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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)

Nyckelord

definitive chemoradiotherapy
esophageal squamous cell carcinoma
locoregional surveillance
neoadjuvant chemoradiotherapy
salvage esophagectomy
Surgery
kirurgi
Oncology
onkologi

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Av författaren/redakt...: Nilsson, Magnus; Olafsdottir, Hal ...; Alexandersson vo ...; Villegas, Fernan ...; Gagliardi, Giova ...; Hellström, Mats; visa fler...; Wang, Qiao-Li; Johansson, Hemmi ...; Gebski, Val; Hedberg, Jakob, ...; Klevebro, Fredri ...; Markar, Sheraz; Smyth, Elizabeth; Lagergren, Perni ...; Al-Haidari, Ghaz ...; Rekstad, Lars Ca ...; Aahlin, Eirik Kj ...; Wallner, Bengt, ...; Edholm, David; Johansson, Jan; Szabo, Eva; Reynolds, John V ...; Pramesh, C.S.; Mummudi, Naveen; Joshi, Amit; Ferri, Lorenzo; Wong, Rebecca K. ...; O’Callaghan, Chr ...; 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, Christian ...; van Laarhoven, H ...; van Berge Henego ...; van Hillegersber ...; Rosati, Riccardo; Piessen, Guillau ...; de Manzoni, Giov ...; Lordick, Florian; visa färre...

Om ämnet

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Cancer och onkol ...

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Kirurgi

Artiklar i publikationen: Frontiers in Onc ...

Av lärosätet: Umeå universitet; Karolinska Institutet; Uppsala universitet; Linköpings universitet

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