Salah-Eddin Al-Batran , 1 , Thorsten O. Goetze 1 , Daniel W. Mueller 1 , Arndt Vogel 2 , Michael Winkler 3 , Sylvie Lorenzen 4 , Alexander Novotny 5 , Claudia Pauligk 1 , Nils Homann 6 , Thomas Jungbluth 7 , Christoph Reissfelder 8 , Karel Caca 9 , Steffen Retter 10 , Eva Horndasch 11 , Julia Gumpp 12 , Claus Bolling 13 , Karl-Hermann Fuchs 14 , Wolfgang Blau 15 , Winfried Padberg 16 , Michael Pohl 17 , Andreas Wunsch 18 , Patrick Michl 19 , Frank Mannes 20 , Matthias Schwarzbach 21 , Harald Schmalenberg 22 , Michael Hohaus 23 , Christian Scholz 24 , Christoph Benckert 25 , Jorge Riera Knorrenschild 26 , Veit Kanngießer 27 , Thomas Zander 28 , Hakan Alakus 29 , Ralf-Dieter Hofheinz 30 , Claus Roedel 31 , Manish A. Shah 32 , Mitsuru Sasako 33 , Dietmar Lorenz 34 , Jakob Izbicki 35 , Wolf O. Bechstein 36 , Hauke Lang 37 , Stefan P. Moenig 38
28 December 2017
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
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.
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.
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.
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.