The RENAISSANCE (AIO-FLOT5) trial

TY - JOUR

T1 - The RENAISSANCE (AIO-FLOT5) trial

T2 - 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

AU - Al-Batran, Salah-Eddin

AU - Goetze, Thorsten O

AU - Mueller, Daniel W

AU - Vogel, Arndt

AU - Winkler, Michael

AU - Lorenzen, Sylvie

AU - Novotny, Alexander

AU - Pauligk, Claudia

AU - Homann, Nils

AU - Jungbluth, Thomas

AU - Reissfelder, Christoph

AU - Caca, Karel

AU - Retter, Steffen

AU - Horndasch, Eva

AU - Gumpp, Julia

AU - Bolling, Claus

AU - Fuchs, Karl-Hermann

AU - Blau, Wolfgang

AU - Padberg, Winfried

AU - Pohl, Michael

AU - Wunsch, Andreas

AU - Michl, Patrick

AU - Mannes, Frank

AU - Schwarzbach, Matthias

AU - Schmalenberg, Harald

AU - Hohaus, Michael

AU - Scholz, Christian

AU - Benckert, Christoph

AU - Knorrenschild, Jorge Riera

AU - Kanngießer, Veit

AU - Zander, Thomas

AU - Alakus, Hakan

AU - Hofheinz, Ralf-Dieter

AU - Roedel, Claus

AU - Shah, Manish A

AU - Sasako, Mitsuru

AU - Lorenz, Dietmar

AU - Izbicki, Jakob

AU - Bechstein, Wolf O

AU - Lang, Hauke

AU - Moenig, Stefan P

PY - 2017/12/28

Y1 - 2017/12/28

N2 - 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.

AB - 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.

KW - Adenocarcinoma/mortality

KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use

KW - Combined Modality Therapy

KW - Esophageal Neoplasms/mortality

KW - Esophagectomy/mortality

KW - Esophagogastric Junction/pathology

KW - Follow-Up Studies

KW - Gastrectomy/mortality

KW - Humans

KW - Lymphatic Metastasis

KW - Prognosis

KW - Prospective Studies

KW - Quality of Life

KW - Stomach Neoplasms/mortality

KW - Survival Rate

U2 - 10.1186/s12885-017-3918-9

DO - 10.1186/s12885-017-3918-9

M3 - SCORING: Journal article

C2 - 29282088

VL - 17

SP - 893

JO - BMC CANCER

JF - BMC CANCER

SN - 1471-2407

IS - 1

ER -