Al-Batran, Salah-Eddin, Goetze, Thorsten O., Mueller, Daniel W., Vogel, Arndt, Winkler, Michael, Lorenzen, Sylvie, Novotny, Alexander, Pauligk, Claudia, Homann, Nils, Jungbluth, Thomas, Reissfelder, Christoph ORCID: 0000-0003-4591-1046, Caca, Karel, Retter, Steffen, Horndasch, Eva, Gumpp, Julia, Bolling, Claus, Fuchs, Karl-Hermann, Blau, Wolfgang, Padberg, Winfried, Pohl, Michael, Wunsch, Andreas, Michl, Patrick, Mannes, Frank, Schwarzbach, Matthias, Schmalenberg, Harald, Hohaus, Michael, Scholz, Christian, Benckert, Christoph, Knorrenschild, Jorge Riera, Kanngiesser, Veit, Zander, Thomas, Alakus, Hakan, Hofheinz, Ralf-Dieter, Roedel, Claus, Shah, Manish A., Sasako, Mitsuru, Lorenz, Dietmar, Izbicki, Jakob, Bechstein, Wolf O., Lang, Hauke and Moenig, Stefan P. (2017). 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. BMC Cancer, 17. LONDON: BIOMED CENTRAL LTD. ISSN 1471-2407

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Al-Batran, Salah-EddinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goetze, Thorsten O.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, Daniel W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vogel, ArndtUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Winkler, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lorenzen, SylvieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Novotny, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pauligk, ClaudiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Homann, NilsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jungbluth, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reissfelder, ChristophUNSPECIFIEDorcid.org/0000-0003-4591-1046UNSPECIFIED
Caca, KarelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Retter, SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Horndasch, EvaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gumpp, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bolling, ClausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fuchs, Karl-HermannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blau, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Padberg, WinfriedUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pohl, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wunsch, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Michl, PatrickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mannes, FrankUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schwarzbach, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmalenberg, HaraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hohaus, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scholz, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Benckert, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Knorrenschild, Jorge RieraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kanngiesser, VeitUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zander, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alakus, HakanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hofheinz, Ralf-DieterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roedel, ClausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shah, Manish A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sasako, MitsuruUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lorenz, DietmarUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Izbicki, JakobUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bechstein, Wolf O.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lang, HaukeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moenig, Stefan P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-207637
DOI: 10.1186/s12885-017-3918-9
Journal or Publication Title: BMC Cancer
Volume: 17
Date: 2017
Publisher: BIOMED CENTRAL LTD
Place of Publication: LONDON
ISSN: 1471-2407
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
GASTRIC-CANCER PATIENTS; CURATIVE RESECTION; GASTROESOPHAGEAL JUNCTION; DOCETAXEL; OXALIPLATIN; MULTICENTER; CISPLATINMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/20763

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