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

被引：174

作者：

Al-Batran, Salah-Eddin ^{[1
]}

Goetze, Thorsten O. ^{[1
]}

Mueller, Daniel W. ^{[1
]}

Vogel, Arndt ^{[2
]}

Winkler, Michael ^{[3
]}

Lorenzen, Sylvie ^{[4
]}

Novotny, Alexander ^{[5
]}

Pauligk, Claudia ^{[1
]}

Homann, Nils ^{[6
]}

Jungbluth, Thomas ^{[7
]}

Reissfelder, Christoph ^{[8
]}

Caca, Karel ^{[9
]}

Retter, Steffen ^{[10
]}

Horndasch, Eva ^{[11
]}

Gumpp, Julia ^{[12
]}

Bolling, Claus ^{[13
]}

Fuchs, Karl-Hermann ^{[14
]}

Blau, Wolfgang ^{[15
]}

Padberg, Winfried ^{[16
]}

Pohl, Michael ^{[17
]}

Wunsch, Andreas ^{[18
]}

Michl, Patrick ^{[19
]}

Mannes, Frank ^{[20
]}

Schwarzbach, Matthias ^{[21
]}

Schmalenberg, Harald ^{[22
]}

Hohaus, Michael ^{[23
]}

Scholz, Christian ^{[24
]}

Benckert, Christoph ^{[25
]}

Knorrenschild, Jorge Riera ^{[26
]}

Kanngiesser, Veit ^{[27
]}

Zander, Thomas ^{[28
]}

Alakus, Hakan ^{[29
]}

Hofheinz, Ralf-Dieter ^{[30
]}

Roedel, Claus ^{[31
]}

Shah, Manish A. ^{[32
]}

Sasako, Mitsuru ^{[33
]}

Lorenz, Dietmar ^{[34
]}

Izbicki, Jakob ^{[35
]}

Bechstein, Wolf O. ^{[36
]}

Lang, Hauke ^{[37
]}

Moenig, Stefan P. ^{[38
]}

机构：

[1] UCT Univ, Ctr Canc, Inst Clin Canc Res (IKF Krankenhaus Nordw, Steinbacher Hohl 2-26, Frankfurt, Germany

[2] Hannover Med Sch, Dept Internal Med, D-30625 Hannover, Germany

[3] Hannover Med Sch, Dept Surg, D-30625 Hannover, Germany

[4] Tech Univ Munich, Klinikum Rechts Isar, Dept Internal Med, D-81675 Munich, Germany

[5] Tech Univ Munich, Klinikum Rechts Isar, Dept Surg, D-81675 Munich, Germany

[6] Acad Teaching Hosp Wolfsburg, Dept Internal Med 2, D-05361 Wolfsburg, Germany

[7] Acad Teaching Hosp Wolfsburg, Dept Surg, D-05361 Wolfsburg, Germany

[8] Univ Hosp Carl Gustav Carus Dresden, Dept Surg, D-01307 Dresden, Germany

[9] Klinikum Ludwigsburg, Dept Internal Med, D-71640 Ludwigsburg, Germany

[10] Klinikum Ludwigsburg, Dept Surg, D-71640 Ludwigsburg, Germany

[11] Kliniken Landkreises Neumarkt, Dept Internal Med, D-92318 Neumarkt, Germany

[12] Kliniken Landkreises Neumarkt, Dept Surg, D-92318 Neumarkt, Germany

[13] Agaples Markus Krankenhaus Frankfurter, Diakonie Kliniken gGmbH, Dept Internal Med, D-60431 Frankfurt, Germany

[14] Agaples Markus Krankenhaus Frankfurter, Diakonie Kliniken gGmbH, Dept Surg, D-60431 Frankfurt, Germany

[15] Giessen Univ Hosp, Dept Med Oncol, D-35392 Giessen, Germany

[16] Giessen Univ Hosp, Dept Surg, D-35392 Giessen, Germany

[17] Ruhr Univ Bochum, Dept Internal Med, D-44801 Bochum, Germany

[18] Ruhr Univ Bochum, Dept Surg, D-44801 Bochum, Germany

[19] Halle Univ Hosp, Dept Med Oncol, D-06120 Halle, Saale, Germany

[20] Halle Univ Hosp, Dept Internal Med, D-06120 Halle, Germany

[21] Klinikum Frankfurt Hochst, Dept Surg, D-65929 Frankfurt, Germany

[22] Stadt Klinikum Dresden, Dept Internal Med 4, D-01067 Dresden, Germany

[23] Stadt Klinikum Dresden, Dept Surg, D-01067 Dresden, Germany

[24] Vivantes Klinikum Urban Berlin, Dept Med Oncol, D-10967 Berlin, Germany

[25] Vivantes Klinikum Urban Berlin, Dept Surg, D-10967 Berlin, Germany

[26] Marburg Univ Hosp, Dept Med Oncol, D-35043 Marburg, Germany

[27] Marburg Univ Hosp, Dept Surg, D-35043 Marburg, Germany

[28] Univ Hosp Koln, Dept Internal Med, D-50937 Cologne, Germany

[29] Univ Hosp Koln, Dept Surg, D-50937 Cologne, Germany

[30] Univ Med Ctr Mannheim, D-68167 Mannheim, Germany

[31] Frankfurt Univ Hosp, Dept Radiat Oncol, D-60590 Frankfurt, Germany

[32] Weill Cornell Med, Dept Med Hematol & Oncol, New York, NY USA

[33] Hyogo Coll Med, Dept Surg, Mukogawa Cho, Nishinomiya, Hyogo, Japan

[34] Sana Klinikum Offenbach, Dept Gen & Visceral Surg, D-63069 Hamburg, Germany

[35] Univ Hamburg Hosp, Dept Surg, D-20246 Hamburg, Germany

[36] Frankfurt Univ Hosp, Dept Surg, D-60590 Hamburg, Germany

[37] Mainz Univ Hosp, Dept Surg, D-55131 Mainz, Germany

[38] Hop Univ Geneve, Serv Chirurg Visceral, CH-1205 Geneva, Switzerland

来源：

BMC CANCER | 2017年 / 17卷

关键词：

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; GASTRIC-CANCER PATIENTS; CURATIVE RESECTION; GASTROESOPHAGEAL JUNCTION; DOCETAXEL; OXALIPLATIN; MULTICENTER; CISPLATIN;

D O I：

10.1186/s12885-017-3918-9

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页数：7

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