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

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.

Contributors

Salah-Eddin Al-Batran: [e-mail]

Thorsten O. Goetze: [e-mail]

Daniel W. Mueller: [e-mail]

Arndt Vogel: [e-mail]

Michael Winkler: [e-mail]

Sylvie Lorenzen: [e-mail]

Alexander Novotny: [e-mail]

Claudia Pauligk: [e-mail]

Nils Homann: [e-mail]

Thomas Jungbluth: [e-mail]

Christoph Reissfelder: [e-mail]

Karel Caca: [e-mail]

Steffen Retter: [e-mail]

Eva Horndasch: [e-mail]

Julia Gumpp: [e-mail]

Claus Bolling: [e-mail]

Karl-Hermann Fuchs: [e-mail]

Wolfgang Blau: [e-mail]

Winfried Padberg: [e-mail]

Michael Pohl: [e-mail]

Andreas Wunsch: [e-mail]

Patrick Michl: [e-mail]

Frank Mannes: [e-mail]

Matthias Schwarzbach: [e-mail]

Harald Schmalenberg: [e-mail]

Michael Hohaus: [e-mail]

Christian Scholz: [e-mail]

Christoph Benckert: [e-mail]

Jorge Riera Knorrenschild: [e-mail]

Veit Kanngießer: [e-mail]

Thomas Zander: [e-mail]

Hakan Alakus: [e-mail]

Ralf-Dieter Hofheinz: [e-mail]

Claus Roedel: [e-mail]

Manish A. Shah: [e-mail]

Mitsuru Sasako: [e-mail]

Dietmar Lorenz: [e-mail]

Jakob Izbicki: [e-mail]

Wolf O. Bechstein: [e-mail]

Hauke Lang: [e-mail]

Stefan P. Moenig: [e-mail]

Journal

Journal ID (nlm-ta): BMC Cancer

Journal ID (iso-abbrev): BMC Cancer

Title: BMC Cancer

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2407

Publication date (Electronic): 28 December 2017

Publication date PMC-release: 28 December 2017

Publication date Collection: 2017

Volume: 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

Publisher ID: 3918

DOI: 10.1186/s12885-017-3918-9

PMC ID: 5745860

PubMed ID: 29282088

Copyright statement: © The Author(s). 2017

License:

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 : Salah-Eddin Al-Batran

Categories

Subject: Study Protocol

Custom metadata

issue-copyright-statement © The Author(s) 2017