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      • Record: found
      • Abstract: found
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      The RENAISSANCE (AIO-FLOT5) trial: effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction – a phase III trial of the German AIO/CAO-V/CAOGI

      , 1 , 1 , 1 , 2 , 3 , 4 , 5 , 1 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38

      BMC Cancer

      BioMed Central

      Oligometastatic cancer, Metastatic gastric cancer, Metastatic gastroesophageal junction cancer, Limited-metastatic disease, Localized peritoneal carcinomatosis, Perioperative chemotherapy, FLOT- regimen, Gastrectomy, Resection of metastases, Quality of life

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          Abstract

          Background

          Historical data indicate that surgical resection may benefit select patients with metastatic gastric and gastroesophageal junction cancer. However, randomized clinical trials are lacking. The current RENAISSANCE trial addresses the potential benefits of surgical intervention in gastric and gastroesophageal junction cancer with limited metastases.

          Methods

          This is a prospective, multicenter, randomized, investigator-initiated phase III trial. Previously untreated patients with limited metastatic stage (retroperitoneal lymph node metastases only or a maximum of one incurable organ site that is potentially resectable or locally controllable with or without retroperitoneal lymph nodes) receive 4 cycles of FLOT chemotherapy alone or with trastuzumab if Her2+. Patients without disease progression after 4 cycles are randomized 1:1 to receive additional chemotherapy cycles or surgical resection of primary and metastases followed by subsequent chemotherapy. 271 patients are to be allocated to the trial, of which at least 176 patients will proceed to randomization. The primary endpoint is overall survival; main secondary endpoints are quality of life assessed by EORTC-QLQ-C30 questionnaire, progression free survival and surgical morbidity and mortality. Recruitment has already started; currently (Feb 2017) 22 patients have been enrolled.

          Discussion

          If the RENAISSANCE concept proves to be effective, this could potentially lead to a new standard of therapy. On the contrary, if the outcome is negative, patients with gastric or GEJ cancer and metastases will no longer be considered candidates for surgical intervention.

          Trial registration

          The article reports of a health care intervention on human participants and is registered on October 12, 2015 under ClinicalTrials.gov Identifier: NCT02578368; EudraCT: 2014–002665-30.

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          Most cited references 12

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          Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial.

          Chemotherapy is the standard of care for incurable advanced gastric cancer. Whether the addition of gastrectomy to chemotherapy improves survival for patients with advanced gastric cancer with a single non-curable factor remains controversial. We aimed to investigate the superiority of gastrectomy followed by chemotherapy versus chemotherapy alone with respect to overall survival in these patients.
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            Value of palliative resection in gastric cancer.

            Western patients with gastric cancer often present with incurable disease. The role of palliative surgical resection is still debatable. Non-curatively treated patients from the Dutch Gastric Cancer Trial were studied to define more accurately which patients might benefit from palliative resection. In the Dutch Gastric Cancer Trial 285 (26 per cent) of the randomized patients were found to have incurable tumours at laparotomy. Four signs of incurability were noted: irresectable tumour (T+), hepatic metastasis (H+), peritoneal metastasis (P+) and distant lymph node metastasis (N4+). Patients had either an explorative laparotomy, a gastroenterostomy, or a resection (partial or total). In the analysis, particular attention was paid to the prognostic factors of age, number of metastatic features, and a combination of these. Overall survival time was greater if a resection was performed (8.1 versus 5.4 months; P < 0.001). For patients aged over 70 years there was still a survival advantage of about 3 months if resection was carried out. Morbidity and perioperative mortality rates in this older age group were, however, high (50 and 20 per cent respectively). For patients with one metastatic site a resection was of significant benefit (survival 10.5 versus 6.7 months; P = 0.034). For patients with two or more metastatic sites resection had no significant survival advantage (5.7 versus 4.6 months; P = 0.084). Combination of these factors indicates that patients aged less than 70 years with one metastatic site will benefit significantly from a palliative resection, in contrast to other combinations of factors. Age as well as the number of metastatic sites should be taken into account when a palliative resection is considered. Palliative resection may be beneficial for patients under 70 years of age if the tumour load is restricted to one metastatic site.
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              Survival benefit of combined curative resection of the stomach (D2 resection) and liver in gastric cancer patients with liver metastases.

              The benefit of surgical resection of liver metastases from gastric cancer has not been well established. The aim of this study was to evaluate the rationale for hepatic resection in patients with hepatic metastases from gastric cancer. Among 10 259 patients diagnosed with gastric adenocarcinoma in the Yonsei University Health System from 1995 to 2005, we reviewed the records of 58 patients with liver-only metastases from gastric cancer who underwent gastric resection regardless of hepatic surgery. The overall 1-year, 3-year, and 5-year survival rates of 41 patients who underwent hepatic resection with curative intent were 75.3%, 31.7%, and 20.8%, respectively, and three patients survived >7 years. Of the 41 patients, 22 had complete resection and 19 had palliative resection. Between the curative and palliative resections, survival rates after curative intent were not different. The number of liver metastasis (solitary or multiple) was a marginally significant prognostic factor for survival. Surgery for liver metastases arising from gastric adenocarcinoma is reasonable if complete resection seems feasible after careful preoperative staging, even if complete resection is not actually achieved. Hepatic resection should be considered as an option for gastric cancer patients with hepatic metastases.
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                Author and article information

                Contributors
                albatran.salah@khnw.de
                Goetze.Thorsten@khnw.de
                Mueller.Daniel@khnw.de
                vogel.arndt@mh-hannover.de
                Winkler.Michael@mh-hannover.de
                sylvie.lorenzen@mri.tum.de
                alexander.novotny@tum.de
                pauligk.claudia@khnw.de
                nils.hohmann@klinikum.wofsburg.de
                Thomas.Jungbluth@klinikum.wofsburg.de
                Christoph.reissfelder@uniklinikum-dresden.de
                karel.caca@kliniken-Ib.de
                Steffen.Retter@kliniken-Ib.de
                eva.horndasch@klinikum.neumarkt.de
                Julia.Gumpp@klinikum.neumarkt.de
                claus.bolling@fdk.info
                karl-hermann.fuchs@fdk.info
                wolfgang.blau@innere.med.uni-giessen.de
                Winfried.Padberg@chiru.med.uni-giessen.de
                Michael.pohl-4@rub.de
                andreas.wunsch@kk-bochum.de
                Patrick.michl@uk-halle.de
                frank.mannes@uk-halle.de
                matthias.schwarzbach@Klinikum-Frankfurt.de
                harals.schmalenberg@khdf.de
                Hohaus-mi@khdf.de
                christianw.scholz@vivantes.de
                Christoph.benckert@vivantes.de
                Jorge.Riera-Knorrenschild@med.uni-marburg.de
                kanngies@med.uni-marburg.de
                Thomas.zander@uk-koeln.de
                hakan.alakus@uk-koeln.de
                ralf.hofheinz@umm.de
                strahlentherapie@kgu.de
                mas9313@med.cornell.edu
                masuyama@hyo-med.ac.jp
                dietmar.lorenz@dgav.de
                izbicki@uke.de
                wolf.bechstein@k.gu
                hauke.lang@unimedizin-mainz.de
                Stefan.Moenig@hcuge.ch
                Journal
                BMC Cancer
                BMC Cancer
                BMC Cancer
                BioMed Central (London )
                1471-2407
                28 December 2017
                28 December 2017
                2017
                : 17
                Affiliations
                [1 ]Institute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488 Frankfurt am Main, Germany
                [2 ]ISNI 0000 0000 9529 9877, GRID grid.10423.34, Department of Internal Medicine, , Hannover Medical School, ; 30625 Hannover, Germany
                [3 ]ISNI 0000 0000 9529 9877, GRID grid.10423.34, Department of Surgery, , Hannover Medical School, ; 30625 Hannover, Germany
                [4 ]ISNI 0000 0004 0477 2438, GRID grid.15474.33, Department of Internal Medicine, , Klinikum rechts der Isar der TU München, ; 81675 Munich, Germany
                [5 ]ISNI 0000 0004 0477 2438, GRID grid.15474.33, Department of Surgery, , Klinikum rechts der Isar der TU München, ; 81675 Munich, Germany
                [6 ]Department of Internal Medicine II, Academic Teaching Hospital Wolfsburg, 05361 Wolfsburg, Germany
                [7 ]Department of Surgery, Academic Teaching Hospital Wolfsburg, 05361 Wolfsburg, Germany
                [8 ]ISNI 0000 0001 1091 2917, GRID grid.412282.f, Department of Surgery, , University Hospital Carl Gustav Carus Dresden, ; 01307 Dresden, Germany
                [9 ]ISNI 0000 0004 0601 4251, GRID grid.419833.4, Department of Internal Medicine, , Klinikum Ludwigsburg, ; 71640 Ludwigsburg, Germany
                [10 ]ISNI 0000 0004 0601 4251, GRID grid.419833.4, Department of Surgery, , Klinikum Ludwigsburg, ; 71640 Ludwigsburg, Germany
                [11 ]Department of Internal Medicine, Kliniken des Landkreises Neumarkt, 92318 Neumarkt, Germany
                [12 ]Department of Surgery, Kliniken des Landkreises Neumarkt, 92318 Neumarkt, Germany
                [13 ]Department of Internal Medicine, Agaplesion Markus Krankenhaus Frankfurter, Diakonie Kliniken gGmbH, 60431 Frankfurt, Germany
                [14 ]Department of Surgery, Agaplesion Markus Krankenhaus Frankfurter Diakonie Kliniken gGmbH, 60431 Frankfurt, Germany
                [15 ]ISNI 0000 0001 2165 8627, GRID grid.8664.c, Department of Medical Oncology, , Gießen University Hospital, ; 35392 Gießen, Germany
                [16 ]ISNI 0000 0001 2165 8627, GRID grid.8664.c, Department of Surgery, , Gießen University Hospital, ; 35392 Gießen, Germany
                [17 ]ISNI 0000 0004 0490 981X, GRID grid.5570.7, Department of Internal Medicine, , Ruhr-University Bochum, ; 44801 Bochum, Germany
                [18 ]ISNI 0000 0004 0490 981X, GRID grid.5570.7, Department of Surgery, , Ruhr-University Bochum, ; 44801 Bochum, Germany
                [19 ]ISNI 0000 0004 0390 1701, GRID grid.461820.9, Department of Medical Oncology, , Halle University Hospital, ; 06120 Halle (Saale), Germany
                [20 ]ISNI 0000 0004 0390 1701, GRID grid.461820.9, Department of Internal Medicine, , Halle University Hospital, ; (Saale), 06120 Halle, Germany
                [21 ]Department of Surgery, Klinikum Frankfurt Höchst, 65929 Frankfurt, Germany
                [22 ]Department of Internal Medicine IV, Städtisches Klinikum Dresden, 01067 Dresden, Germany
                [23 ]Department of Surgery, Städtisches Klinikum Dresden, 01067 Dresden, Germany
                [24 ]ISNI 0000 0004 0476 8412, GRID grid.433867.d, Department of Medical Oncology, , Vivantes Klinikum Am Urban Berlin, ; 10967 Berlin, Germany
                [25 ]ISNI 0000 0004 0476 8412, GRID grid.433867.d, Department of Surgery, , Vivantes Klinikum Am Urban Berlin, ; 10967 Berlin, Germany
                [26 ]ISNI 0000 0000 8584 9230, GRID grid.411067.5, Department of Medical Oncology, , Marburg University Hospital, ; 35043 Marburg, Germany
                [27 ]ISNI 0000 0000 8584 9230, GRID grid.411067.5, Department of Surgery, , Marburg University Hospital, ; 35043 Marburg, Germany
                [28 ]ISNI 0000 0000 8852 305X, GRID grid.411097.a, Department of Internal Medicine, , University Hospital Köln, ; 50937 Köln, Germany
                [29 ]ISNI 0000 0000 8852 305X, GRID grid.411097.a, Department of Surgery, , University Hospital Köln, ; 50937 Köln, Germany
                [30 ]ISNI 0000 0001 2162 1728, GRID grid.411778.c, University Medical Center Mannheim, ; 68167 Mannheim, Germany
                [31 ]ISNI 0000 0004 1936 9721, GRID grid.7839.5, Department of Radiation- Oncology, , Frankfurt University Hospital, ; 60590 Frankfurt, Germany
                [32 ]ISNI 000000041936877X, GRID grid.5386.8, Department of Medicine Hematology and Oncology, , Weill Cornell Medicine, ; New York, USA
                [33 ]ISNI 0000 0000 9142 153X, GRID grid.272264.7, Department of Surgery, , Hyogo College of Medicine, ; Mukogawa-cho, Nishinomiya, Hyogo Japan
                [34 ]GRID grid.419837.0, Department of General and Visceral Surgery, , Sana- Klinikum Offenbach, ; 63069 Offenbach, Hamburg, Germany
                [35 ]ISNI 0000 0001 2287 2617, GRID grid.9026.d, Department of Surgery, , Hamburg University Hospital, ; 20246 Hamburg, Germany
                [36 ]ISNI 0000 0001 2180 3484, GRID grid.13648.38, Department of Surgery, , Frankfurt University Hospital, ; 60590 Frankfurt, Hamburg, Germany
                [37 ]GRID grid.410607.4, Department of Surgery, , Mainz University Hospital, ; 55131 Mainz, Germany
                [38 ]ISNI 0000 0001 0721 9812, GRID grid.150338.c, Hôpitaux Universitaires de Genève, Service de Chirurgie viscéral, ; 1205 Genève, Switzerland
                Article
                3918
                10.1186/s12885-017-3918-9
                5745860
                29282088
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001659, Deutsche Forschungsgemeinschaft;
                Award ID: AL 1817/1‐1
                Award Recipient :
                Categories
                Study Protocol
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                © The Author(s) 2017

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