TOPGEAR: a randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric cancer (an international, intergroup trial of the AGITG/TROG/EORTC/NCIC CTG).
Identifieur interne : 002622 ( PubMed/Checkpoint ); précédent : 002621; suivant : 002623TOPGEAR: a randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric cancer (an international, intergroup trial of the AGITG/TROG/EORTC/NCIC CTG).
Auteurs : Trevor Leong [Australie] ; B Mark Smithers [Australie] ; Michael Michael [Australie] ; Val Gebski [Australie] ; Alex Boussioutas [Australie] ; Danielle Miller [Australie] ; John Simes [Australie] ; John Zalcberg [Australie] ; Karin Haustermans [Belgique] ; Florian Lordick [Allemagne] ; Christoph Schuhmacher [France] ; Carol Swallow [Canada] ; Gail Darling [Canada] ; Rebecca Wong [Canada]Source :
- BMC cancer [ 1471-2407 ] ; 2015.
Descripteurs français
- KwdFr :
- Analyse de survie, Chimioradiothérapie adjuvante (), Cisplatine (administration et posologie), Cisplatine (usage thérapeutique), Fluorouracil (administration et posologie), Fluorouracil (usage thérapeutique), Humains, Jonction oesogastrique (), Jonction oesogastrique (anatomopathologie), Jonction oesogastrique (effets des radiations), Protocoles de polychimiothérapie antinéoplasique (administration et posologie), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Résultat thérapeutique, Soins préopératoires, Soins périopératoires, Tumeurs de l'estomac (), Tumeurs de l'estomac (radiothérapie), Tumeurs de l'estomac (traitement médicamenteux), Épirubicine (administration et posologie), Épirubicine (usage thérapeutique).
- MESH :
- administration et posologie : Cisplatine, Fluorouracil, Protocoles de polychimiothérapie antinéoplasique, Épirubicine.
- anatomopathologie : Jonction oesogastrique.
- effets des radiations : Jonction oesogastrique.
- radiothérapie : Tumeurs de l'estomac.
- traitement médicamenteux : Tumeurs de l'estomac.
- usage thérapeutique : Cisplatine, Fluorouracil, Protocoles de polychimiothérapie antinéoplasique, Épirubicine.
- Analyse de survie, Chimioradiothérapie adjuvante, Humains, Jonction oesogastrique, Résultat thérapeutique, Soins préopératoires, Soins périopératoires, Tumeurs de l'estomac.
English descriptors
- KwdEn :
- Antineoplastic Combined Chemotherapy Protocols (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Chemoradiotherapy, Adjuvant (methods), Cisplatin (administration & dosage), Cisplatin (therapeutic use), Epirubicin (administration & dosage), Epirubicin (therapeutic use), Esophagogastric Junction (drug effects), Esophagogastric Junction (pathology), Esophagogastric Junction (radiation effects), Fluorouracil (administration & dosage), Fluorouracil (therapeutic use), Humans, Perioperative Care, Preoperative Care, Stomach Neoplasms (drug therapy), Stomach Neoplasms (radiotherapy), Stomach Neoplasms (surgery), Survival Analysis, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Cisplatin, Epirubicin, Fluorouracil.
- administration & dosage : Antineoplastic Combined Chemotherapy Protocols.
- drug effects : Esophagogastric Junction.
- drug therapy : Stomach Neoplasms.
- methods : Chemoradiotherapy, Adjuvant.
- pathology : Esophagogastric Junction.
- radiation effects : Esophagogastric Junction.
- radiotherapy : Stomach Neoplasms.
- surgery : Stomach Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols, Cisplatin, Epirubicin, Fluorouracil.
- Humans, Perioperative Care, Preoperative Care, Survival Analysis, Treatment Outcome.
Abstract
The optimal management of patients with resectable gastric cancer continues to evolve in Western countries. Following publication of the US Intergroup 0116 and UK Medical Research Council MAGIC trials, there are now two standards of care for adjuvant therapy in resectable gastric cancer, at least in the Western world: postoperative chemoradiotherapy and perioperative epirubicin/cisplatin/fluorouracil (ECF) chemotherapy. We hypothesize that adding chemoradiation to standard perioperative ECF chemotherapy will achieve further survival gains. We also believe there are advantages to administering chemoradiation in the preoperative rather than postoperative setting. In this article, we describe the TOPGEAR trial, which is a randomised phase III trial comparing control arm therapy of perioperative ECF chemotherapy with experimental arm therapy of preoperative chemoradiation plus perioperative ECF chemotherapy.
DOI: 10.1186/s12885-015-1529-x
PubMed: 26194186
Affiliations:
- Allemagne, Australie, Belgique, Canada, France
- District de Leipzig, Nouvelle-Galles du Sud, Saxe (Land), Île-de-France
- Leipzig, Paris, Sydney
- Université de Sydney
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Clinical Research Infrastructure Network, ECRIN-ERIC, Paris Biopark, 5 rue Watt, 75013, Paris, France. christoph.schuhmacher@ecrin.org.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>European Clinical Research Infrastructure Network, ECRIN-ERIC, Paris Biopark, 5 rue Watt, 75013, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Swallow, Carol" sort="Swallow, Carol" uniqKey="Swallow C" first="Carol" last="Swallow">Carol Swallow</name><affiliation wicri:level="1"><nlm:affiliation>Mount Sinai Hospital, Rm 1225, 600 University Avenue, Toronto, ON, M5G 1X5, Canada. cswallow@mtsinai.on.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Mount Sinai Hospital, Rm 1225, 600 University Avenue, Toronto, ON, M5G 1X5</wicri:regionArea><wicri:noRegion>M5G 1X5</wicri:noRegion></affiliation></author><author><name sortKey="Darling, Gail" sort="Darling, Gail" uniqKey="Darling G" first="Gail" last="Darling">Gail Darling</name><affiliation wicri:level="1"><nlm:affiliation>Toronto General Hospital, 9N-955, 200 Elizabeth St, Toronto, ON, M5G 2C4, Canada. 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Rebecca.Wong@rmp.uhn.on.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Princess Margaret Hospital, Rm 5-807, 610 University Avenue, Toronto, M5G 2M9</wicri:regionArea><wicri:noRegion>M5G 2M9</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26194186</idno><idno type="pmid">26194186</idno><idno type="doi">10.1186/s12885-015-1529-x</idno><idno type="wicri:Area/PubMed/Corpus">002B34</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002B34</idno><idno type="wicri:Area/PubMed/Curation">002A62</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">002A62</idno><idno type="wicri:Area/PubMed/Checkpoint">002A62</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">002A62</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">TOPGEAR: a randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric cancer (an international, intergroup trial of the AGITG/TROG/EORTC/NCIC CTG).</title><author><name sortKey="Leong, Trevor" sort="Leong, Trevor" uniqKey="Leong T" first="Trevor" last="Leong">Trevor Leong</name><affiliation wicri:level="1"><nlm:affiliation>Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Victoria, 8006, Australia. Trevor.Leong@petermac.org.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Victoria, 8006</wicri:regionArea><wicri:noRegion>8006</wicri:noRegion></affiliation></author><author><name sortKey="Smithers, B Mark" sort="Smithers, B Mark" uniqKey="Smithers B" first="B Mark" last="Smithers">B Mark Smithers</name><affiliation wicri:level="1"><nlm:affiliation>Upper Gastro-intestinal and Soft Tissue Unit, School of Medicine, University of Queensland, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD, 4102, Australia. m.smithers@uq.edu.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Upper Gastro-intestinal and Soft Tissue Unit, School of Medicine, University of Queensland, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD, 4102</wicri:regionArea><wicri:noRegion>4102</wicri:noRegion></affiliation></author><author><name sortKey="Michael, Michael" sort="Michael, Michael" uniqKey="Michael M" first="Michael" last="Michael">Michael Michael</name><affiliation wicri:level="1"><nlm:affiliation>Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Victoria, 8006, Australia. Michael.Michael@petermac.org.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Victoria, 8006</wicri:regionArea><wicri:noRegion>8006</wicri:noRegion></affiliation></author><author><name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name><affiliation wicri:level="4"><nlm:affiliation>NHMRC Clinical Trials Centre, University of Sydney, Locked bag 77, Camperdown, NSW, 1450, Australia. val@ctc.usyd.edu.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>NHMRC Clinical Trials Centre, University of Sydney, Locked bag 77, Camperdown, NSW, 1450</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Boussioutas, Alex" sort="Boussioutas, Alex" uniqKey="Boussioutas A" first="Alex" last="Boussioutas">Alex Boussioutas</name><affiliation wicri:level="1"><nlm:affiliation>Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Victoria, 8006, Australia. alex.boussioutas@petermac.org.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Victoria, 8006</wicri:regionArea><wicri:noRegion>8006</wicri:noRegion></affiliation></author><author><name sortKey="Miller, Danielle" sort="Miller, Danielle" uniqKey="Miller D" first="Danielle" last="Miller">Danielle Miller</name><affiliation wicri:level="4"><nlm:affiliation>NHMRC Clinical Trials Centre, University of Sydney, Locked bag 77, Camperdown, NSW, 1450, Australia. danielle.miller@ctc.usyd.edu.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>NHMRC Clinical Trials Centre, University of Sydney, Locked bag 77, Camperdown, NSW, 1450</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Simes, John" sort="Simes, John" uniqKey="Simes J" first="John" last="Simes">John Simes</name><affiliation wicri:level="4"><nlm:affiliation>NHMRC Clinical Trials Centre, University of Sydney, Locked bag 77, Camperdown, NSW, 1450, Australia. john@ctc.usyd.edu.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>NHMRC Clinical Trials Centre, University of Sydney, Locked bag 77, Camperdown, NSW, 1450</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Zalcberg, John" sort="Zalcberg, John" uniqKey="Zalcberg J" first="John" last="Zalcberg">John Zalcberg</name><affiliation wicri:level="1"><nlm:affiliation>School of Public Health and Preventive Medicine, Monash University, Level 5 The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia. john.zalcberg@monash.edu.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>School of Public Health and Preventive Medicine, Monash University, Level 5 The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004</wicri:regionArea><wicri:noRegion>3004</wicri:noRegion></affiliation></author><author><name sortKey="Haustermans, Karin" sort="Haustermans, Karin" uniqKey="Haustermans K" first="Karin" last="Haustermans">Karin Haustermans</name><affiliation wicri:level="1"><nlm:affiliation>Radiation Oncology, University Hospitals Leuven, Department of Oncology, KU, Leuven, Belgium. karin.haustermans@uzleuven.be.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Radiation Oncology, University Hospitals Leuven, Department of Oncology, KU, Leuven</wicri:regionArea><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Lordick, Florian" sort="Lordick, Florian" uniqKey="Lordick F" first="Florian" last="Lordick">Florian Lordick</name><affiliation wicri:level="3"><nlm:affiliation>University Cancer Center Leipzig (UCCL), University Medicine Leipzig, Leipzig, Germany. florian.lordick@medizin.uni-leipzig.de.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>University Cancer Center Leipzig (UCCL), University Medicine Leipzig, Leipzig</wicri:regionArea><placeName><region type="land" nuts="1">Saxe (Land)</region><region type="district" nuts="2">District de Leipzig</region><settlement type="city">Leipzig</settlement></placeName></affiliation></author><author><name sortKey="Schuhmacher, Christoph" sort="Schuhmacher, Christoph" uniqKey="Schuhmacher C" first="Christoph" last="Schuhmacher">Christoph Schuhmacher</name><affiliation wicri:level="3"><nlm:affiliation>European Clinical Research Infrastructure Network, ECRIN-ERIC, Paris Biopark, 5 rue Watt, 75013, Paris, France. christoph.schuhmacher@ecrin.org.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>European Clinical Research Infrastructure Network, ECRIN-ERIC, Paris Biopark, 5 rue Watt, 75013, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Swallow, Carol" sort="Swallow, Carol" uniqKey="Swallow C" first="Carol" last="Swallow">Carol Swallow</name><affiliation wicri:level="1"><nlm:affiliation>Mount Sinai Hospital, Rm 1225, 600 University Avenue, Toronto, ON, M5G 1X5, Canada. cswallow@mtsinai.on.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Mount Sinai Hospital, Rm 1225, 600 University Avenue, Toronto, ON, M5G 1X5</wicri:regionArea><wicri:noRegion>M5G 1X5</wicri:noRegion></affiliation></author><author><name sortKey="Darling, Gail" sort="Darling, Gail" uniqKey="Darling G" first="Gail" last="Darling">Gail Darling</name><affiliation wicri:level="1"><nlm:affiliation>Toronto General Hospital, 9N-955, 200 Elizabeth St, Toronto, ON, M5G 2C4, Canada. Gail.Darling@uhn.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto General Hospital, 9N-955, 200 Elizabeth St, Toronto, ON, M5G 2C4</wicri:regionArea><wicri:noRegion>M5G 2C4</wicri:noRegion></affiliation></author><author><name sortKey="Wong, Rebecca" sort="Wong, Rebecca" uniqKey="Wong R" first="Rebecca" last="Wong">Rebecca Wong</name><affiliation wicri:level="1"><nlm:affiliation>Princess Margaret Hospital, Rm 5-807, 610 University Avenue, Toronto, M5G 2M9, Canada. Rebecca.Wong@rmp.uhn.on.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Princess Margaret Hospital, Rm 5-807, 610 University Avenue, Toronto, M5G 2M9</wicri:regionArea><wicri:noRegion>M5G 2M9</wicri:noRegion></affiliation></author></analytic><series><title level="j">BMC cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols (administration & dosage)</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Chemoradiotherapy, Adjuvant (methods)</term><term>Cisplatin (administration & dosage)</term><term>Cisplatin (therapeutic use)</term><term>Epirubicin (administration & dosage)</term><term>Epirubicin (therapeutic use)</term><term>Esophagogastric Junction (drug effects)</term><term>Esophagogastric Junction (pathology)</term><term>Esophagogastric Junction (radiation effects)</term><term>Fluorouracil (administration & dosage)</term><term>Fluorouracil (therapeutic use)</term><term>Humans</term><term>Perioperative Care</term><term>Preoperative Care</term><term>Stomach Neoplasms (drug therapy)</term><term>Stomach Neoplasms (radiotherapy)</term><term>Stomach Neoplasms (surgery)</term><term>Survival Analysis</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Analyse de survie</term><term>Chimioradiothérapie adjuvante ()</term><term>Cisplatine (administration et posologie)</term><term>Cisplatine (usage thérapeutique)</term><term>Fluorouracil (administration et posologie)</term><term>Fluorouracil (usage thérapeutique)</term><term>Humains</term><term>Jonction oesogastrique ()</term><term>Jonction oesogastrique (anatomopathologie)</term><term>Jonction oesogastrique (effets des radiations)</term><term>Protocoles de polychimiothérapie antinéoplasique (administration et posologie)</term><term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term><term>Résultat thérapeutique</term><term>Soins préopératoires</term><term>Soins périopératoires</term><term>Tumeurs de l'estomac ()</term><term>Tumeurs de l'estomac (radiothérapie)</term><term>Tumeurs de l'estomac (traitement médicamenteux)</term><term>Épirubicine (administration et posologie)</term><term>Épirubicine (usage thérapeutique)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Cisplatin</term><term>Epirubicin</term><term>Fluorouracil</term></keywords><keywords scheme="MESH" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Cisplatine</term><term>Fluorouracil</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Épirubicine</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Jonction oesogastrique</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Esophagogastric Junction</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Stomach Neoplasms</term></keywords><keywords scheme="MESH" qualifier="effets des radiations" xml:lang="fr"><term>Jonction oesogastrique</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Chemoradiotherapy, Adjuvant</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Esophagogastric Junction</term></keywords><keywords scheme="MESH" qualifier="radiation effects" xml:lang="en"><term>Esophagogastric Junction</term></keywords><keywords scheme="MESH" qualifier="radiotherapy" xml:lang="en"><term>Stomach Neoplasms</term></keywords><keywords scheme="MESH" qualifier="radiothérapie" xml:lang="fr"><term>Tumeurs de l'estomac</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Stomach Neoplasms</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Cisplatin</term><term>Epirubicin</term><term>Fluorouracil</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs de l'estomac</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Cisplatine</term><term>Fluorouracil</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Épirubicine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term><term>Perioperative Care</term><term>Preoperative Care</term><term>Survival Analysis</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Analyse de survie</term><term>Chimioradiothérapie adjuvante</term><term>Humains</term><term>Jonction oesogastrique</term><term>Résultat thérapeutique</term><term>Soins préopératoires</term><term>Soins périopératoires</term><term>Tumeurs de l'estomac</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The optimal management of patients with resectable gastric cancer continues to evolve in Western countries. Following publication of the US Intergroup 0116 and UK Medical Research Council MAGIC trials, there are now two standards of care for adjuvant therapy in resectable gastric cancer, at least in the Western world: postoperative chemoradiotherapy and perioperative epirubicin/cisplatin/fluorouracil (ECF) chemotherapy. We hypothesize that adding chemoradiation to standard perioperative ECF chemotherapy will achieve further survival gains. We also believe there are advantages to administering chemoradiation in the preoperative rather than postoperative setting. In this article, we describe the TOPGEAR trial, which is a randomised phase III trial comparing control arm therapy of perioperative ECF chemotherapy with experimental arm therapy of preoperative chemoradiation plus perioperative ECF chemotherapy.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26194186</PMID><DateCreated><Year>2015</Year><Month>07</Month><Day>21</Day></DateCreated><DateCompleted><Year>2016</Year><Month>04</Month><Day>28</Day></DateCompleted><DateRevised><Year>2015</Year><Month>07</Month><Day>29</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1471-2407</ISSN><JournalIssue CitedMedium="Internet"><Volume>15</Volume><PubDate><Year>2015</Year><Month>Jul</Month><Day>21</Day></PubDate></JournalIssue><Title>BMC cancer</Title><ISOAbbreviation>BMC Cancer</ISOAbbreviation></Journal><ArticleTitle>TOPGEAR: a randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric cancer (an international, intergroup trial of the AGITG/TROG/EORTC/NCIC CTG).</ArticleTitle><Pagination><MedlinePgn>532</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s12885-015-1529-x</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The optimal management of patients with resectable gastric cancer continues to evolve in Western countries. Following publication of the US Intergroup 0116 and UK Medical Research Council MAGIC trials, there are now two standards of care for adjuvant therapy in resectable gastric cancer, at least in the Western world: postoperative chemoradiotherapy and perioperative epirubicin/cisplatin/fluorouracil (ECF) chemotherapy. We hypothesize that adding chemoradiation to standard perioperative ECF chemotherapy will achieve further survival gains. We also believe there are advantages to administering chemoradiation in the preoperative rather than postoperative setting. In this article, we describe the TOPGEAR trial, which is a randomised phase III trial comparing control arm therapy of perioperative ECF chemotherapy with experimental arm therapy of preoperative chemoradiation plus perioperative ECF chemotherapy.</AbstractText><AbstractText Label="METHODS/DESIGN" NlmCategory="METHODS">Eligible patients with resectable adenocarcinoma of the stomach or gastroesophageal junction will be randomized to receive either perioperative chemotherapy alone (3 preoperative and 3 postoperative cycles of ECF) or perioperative chemotherapy plus preoperative chemoradiation. In the chemoradiation arm, patients receive 2 cycles of ECF plus chemoradiation prior to surgery, and then following surgery 3 further cycles of ECF are given. The trial is being conducted in two Parts; Part 1 (phase II component) has recruited 120 patients with the aim of assessing feasibility, safety and preliminary efficacy of preoperative chemoradiation. Part 2 (phase III component) will recruit a further 632 patients to provide a total sample size of 752 patients. The primary endpoint of the phase III trial is overall survival. The trial includes quality of life and biological substudies, as well as a health economic evaluation. In addition, the trial incorporates a rigorous quality assurance program that includes real time central review of radiotherapy plans and central review of surgical technique.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">TOPGEAR is an international, intergroup collaboration led by the Australasian Gastro-Intestinal Trials Group (AGITG), in collaboration with the Trans-Tasman Radiation Oncology Group (TROG), European Organisation for Research and Treatment of Cancer (EORTC) and the NCIC Clinical Trials Group. It addresses a globally significant question that will help inform future international standards for clinical practice in resectable gastric cancer.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Australian New Zealand Clinical Trials Registry: ACTRN12609000035224 . Registered 30 May 2009.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Leong</LastName><ForeName>Trevor</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Victoria, 8006, Australia. Trevor.Leong@petermac.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Smithers</LastName><ForeName>B Mark</ForeName><Initials>BM</Initials><AffiliationInfo><Affiliation>Upper Gastro-intestinal and Soft Tissue Unit, School of Medicine, University of Queensland, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD, 4102, Australia. m.smithers@uq.edu.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Michael</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Victoria, 8006, Australia. Michael.Michael@petermac.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gebski</LastName><ForeName>Val</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>NHMRC Clinical Trials Centre, University of Sydney, Locked bag 77, Camperdown, NSW, 1450, Australia. val@ctc.usyd.edu.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boussioutas</LastName><ForeName>Alex</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Victoria, 8006, Australia. alex.boussioutas@petermac.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Miller</LastName><ForeName>Danielle</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>NHMRC Clinical Trials Centre, University of Sydney, Locked bag 77, Camperdown, NSW, 1450, Australia. danielle.miller@ctc.usyd.edu.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Simes</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>NHMRC Clinical Trials Centre, University of Sydney, Locked bag 77, Camperdown, NSW, 1450, Australia. john@ctc.usyd.edu.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zalcberg</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>School of Public Health and Preventive Medicine, Monash University, Level 5 The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia. john.zalcberg@monash.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Haustermans</LastName><ForeName>Karin</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Radiation Oncology, University Hospitals Leuven, Department of Oncology, KU, Leuven, Belgium. karin.haustermans@uzleuven.be.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lordick</LastName><ForeName>Florian</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>University Cancer Center Leipzig (UCCL), University Medicine Leipzig, Leipzig, Germany. florian.lordick@medizin.uni-leipzig.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schuhmacher</LastName><ForeName>Christoph</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>European Clinical Research Infrastructure Network, ECRIN-ERIC, Paris Biopark, 5 rue Watt, 75013, Paris, France. christoph.schuhmacher@ecrin.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Swallow</LastName><ForeName>Carol</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Mount Sinai Hospital, Rm 1225, 600 University Avenue, Toronto, ON, M5G 1X5, Canada. cswallow@mtsinai.on.ca.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Darling</LastName><ForeName>Gail</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Toronto General Hospital, 9N-955, 200 Elizabeth St, Toronto, ON, M5G 2C4, Canada. Gail.Darling@uhn.ca.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wong</LastName><ForeName>Rebecca</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Princess Margaret Hospital, Rm 5-807, 610 University Avenue, Toronto, M5G 2M9, Canada. Rebecca.Wong@rmp.uhn.on.ca.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ANZCTR</DataBankName><AccessionNumberList><AccessionNumber>ACTRN12609000035224</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>07</Month><Day>21</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMC Cancer</MedlineTA><NlmUniqueID>100967800</NlmUniqueID><ISSNLinking>1471-2407</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>3Z8479ZZ5X</RegistryNumber><NameOfSubstance UI="D015251">Epirubicin</NameOfSubstance></Chemical><Chemical><RegistryNumber>Q20Q21Q62J</RegistryNumber><NameOfSubstance UI="D002945">Cisplatin</NameOfSubstance></Chemical><Chemical><RegistryNumber>U3P01618RT</RegistryNumber><NameOfSubstance UI="D005472">Fluorouracil</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Cancer Treat Rev. 2007 Dec;33(8):729-40</RefSource><PMID Version="1">17935888</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Radiother Oncol. 2009 Aug;92(2):176-83</RefSource><PMID Version="1">19586672</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2001 Sep 6;345(10):725-30</RefSource><PMID Version="1">11547741</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Oncol. 2004 Jul 15;22(14):2774-80</RefSource><PMID Version="1">15254045</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Ann Surg. 1989 Nov;210(5):596-602</RefSource><PMID Version="1">2818028</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2006 Jul 6;355(1):11-20</RefSource><PMID Version="1">16822992</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Oncol. 2006 Aug 20;24(24):3953-8</RefSource><PMID Version="1">16921048</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D059186" MajorTopicYN="N">Chemoradiotherapy, Adjuvant</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002945" MajorTopicYN="N">Cisplatin</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015251" MajorTopicYN="N">Epirubicin</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004943" MajorTopicYN="N">Esophagogastric Junction</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName><QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName><QualifierName UI="Q000528" MajorTopicYN="N">radiation effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005472" MajorTopicYN="N">Fluorouracil</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019990" MajorTopicYN="N">Perioperative Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011300" MajorTopicYN="N">Preoperative Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013274" MajorTopicYN="N">Stomach Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000532" MajorTopicYN="Y">radiotherapy</QualifierName><QualifierName UI="Q000601" MajorTopicYN="N">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016019" MajorTopicYN="N">Survival Analysis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4507314</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>05</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>06</Month><Day>30</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>7</Month><Day>22</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>7</Month><Day>22</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>4</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26194186</ArticleId><ArticleId IdType="doi">10.1186/s12885-015-1529-x</ArticleId><ArticleId IdType="pii">10.1186/s12885-015-1529-x</ArticleId><ArticleId IdType="pmc">PMC4507314</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>Canada</li><li>France</li></country><region><li>District de Leipzig</li><li>Nouvelle-Galles du Sud</li><li>Saxe (Land)</li><li>Île-de-France</li></region><settlement><li>Leipzig</li><li>Paris</li><li>Sydney</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><country name="Australie"><noRegion><name sortKey="Leong, Trevor" sort="Leong, Trevor" uniqKey="Leong T" first="Trevor" last="Leong">Trevor Leong</name></noRegion><name sortKey="Boussioutas, Alex" sort="Boussioutas, Alex" uniqKey="Boussioutas A" first="Alex" last="Boussioutas">Alex Boussioutas</name><name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name><name sortKey="Michael, Michael" sort="Michael, Michael" uniqKey="Michael M" first="Michael" last="Michael">Michael Michael</name><name sortKey="Miller, Danielle" sort="Miller, Danielle" uniqKey="Miller D" first="Danielle" last="Miller">Danielle Miller</name><name sortKey="Simes, John" sort="Simes, John" uniqKey="Simes J" first="John" last="Simes">John Simes</name><name sortKey="Smithers, B Mark" sort="Smithers, B Mark" uniqKey="Smithers B" first="B Mark" last="Smithers">B Mark Smithers</name><name sortKey="Zalcberg, John" sort="Zalcberg, John" uniqKey="Zalcberg J" first="John" last="Zalcberg">John Zalcberg</name></country><country name="Belgique"><noRegion><name sortKey="Haustermans, Karin" sort="Haustermans, Karin" uniqKey="Haustermans K" first="Karin" last="Haustermans">Karin Haustermans</name></noRegion></country><country name="Allemagne"><region name="Saxe (Land)"><name sortKey="Lordick, Florian" sort="Lordick, Florian" uniqKey="Lordick F" first="Florian" last="Lordick">Florian Lordick</name></region></country><country name="France"><region name="Île-de-France"><name sortKey="Schuhmacher, Christoph" sort="Schuhmacher, Christoph" uniqKey="Schuhmacher C" first="Christoph" last="Schuhmacher">Christoph Schuhmacher</name></region></country><country name="Canada"><noRegion><name sortKey="Swallow, Carol" sort="Swallow, Carol" uniqKey="Swallow C" first="Carol" last="Swallow">Carol Swallow</name></noRegion><name sortKey="Darling, Gail" sort="Darling, Gail" uniqKey="Darling G" first="Gail" last="Darling">Gail Darling</name><name sortKey="Wong, Rebecca" sort="Wong, Rebecca" uniqKey="Wong R" first="Rebecca" last="Wong">Rebecca Wong</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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