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

作者：Salah‐Eddin Al‐Batran, Thorsten Oliver Goetze, Daniel Wilhelm Mueller, Arndt Vogel, Michael Winkler, Sylvie Lorenzen, Alexander Novotny, Claudia Pauligk, Nils Homann, Thomas Jungbluth, Christoph Reißfelder, Karel Caca, Steffen Retter, Eva Horndasch, Julia Gumpp, Claus Bolling, Karl–Hermann Fuchs, Wolfgang Blau, Winfried M. Padberg, Michael Pohl, Andreas Wünsch, Patrick Michl, Frank Mannes, Matthias Schwarzbach, Harald Schmalenberg, Michael Hohaus, Christian Wilfried Scholz, Christoph Benckert, Jorge Riera Knorrenschild, Veit Kanngießer, Thomas Zander, Hakan Alakus, Ralf‐Dieter Hofheinz, Claus Röedel, Manish A. Shah, Mitsuru Sasako, Dietmar Lorenz, Jakob Robert Izbicki, Wolf O. Bechstein, Hauke Lang, Stefan Paul Moenig · 发表于：BMC Cancer · 年份：2017 · DOI：10.1186/s12885-017-3918-9 · 被引用次数：236 · 研究领域：Gastric Cancer Management and Outcomes、Esophageal Cancer Research and Treatment、Gastrointestinal Tumor Research and Treatment

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, ...