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.
- Al-Batran SE Institute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488, Frankfurt am Main, Germany. albatran.salah@khnw.de.
- Goetze TO Institute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488, Frankfurt am Main, Germany.
- Mueller DW Institute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488, Frankfurt am Main, Germany.
- Vogel A Department of Internal Medicine, Hannover Medical School, 30625, Hannover, Germany.
- Winkler M Department of Surgery, Hannover Medical School, 30625, Hannover, Germany.
- Lorenzen S Department of Internal Medicine, Klinikum rechts der Isar der TU München, 81675, Munich, Germany.
- Novotny A Department of Surgery, Klinikum rechts der Isar der TU München, 81675, Munich, Germany.
- Pauligk C Institute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488, Frankfurt am Main, Germany.
- Homann N Department of Internal Medicine II, Academic Teaching Hospital Wolfsburg, 05361, Wolfsburg, Germany.
- Jungbluth T Department of Surgery, Academic Teaching Hospital Wolfsburg, 05361, Wolfsburg, Germany.
- Reissfelder C Department of Surgery, University Hospital Carl Gustav Carus Dresden, 01307, Dresden, Germany.
- Caca K Department of Internal Medicine, Klinikum Ludwigsburg, 71640, Ludwigsburg, Germany.
- Retter S Department of Surgery, Klinikum Ludwigsburg, 71640, Ludwigsburg, Germany.
- Horndasch E Department of Internal Medicine, Kliniken des Landkreises Neumarkt, 92318, Neumarkt, Germany.
- Gumpp J Department of Surgery, Kliniken des Landkreises Neumarkt, 92318, Neumarkt, Germany.
- Bolling C Department of Internal Medicine, Agaplesion Markus Krankenhaus Frankfurter, Diakonie Kliniken gGmbH, 60431, Frankfurt, Germany.
- Fuchs KH Department of Surgery, Agaplesion Markus Krankenhaus Frankfurter Diakonie Kliniken gGmbH, 60431, Frankfurt, Germany.
- Blau W Department of Medical Oncology, Gießen University Hospital, 35392, Gießen, Germany.
- Padberg W Department of Surgery, Gießen University Hospital, 35392, Gießen, Germany.
- Pohl M Department of Internal Medicine, Ruhr-University Bochum, 44801, Bochum, Germany.
- Wunsch A Department of Surgery, Ruhr-University Bochum, 44801, Bochum, Germany.
- Michl P Department of Medical Oncology, Halle University Hospital, 06120, Halle (Saale), Germany.
- Mannes F Department of Internal Medicine, Halle University Hospital, (Saale), 06120, Halle, Germany.
- Schwarzbach M Department of Surgery, Klinikum Frankfurt Höchst, 65929, Frankfurt, Germany.
- Schmalenberg H Department of Internal Medicine IV, Städtisches Klinikum Dresden, 01067, Dresden, Germany.
- Hohaus M Department of Surgery, Städtisches Klinikum Dresden, 01067, Dresden, Germany.
- Scholz C Department of Medical Oncology, Vivantes Klinikum Am Urban Berlin, 10967, Berlin, Germany.
- Benckert C Department of Surgery, Vivantes Klinikum Am Urban Berlin, 10967, Berlin, Germany.
- Knorrenschild JR Department of Medical Oncology, Marburg University Hospital, 35043, Marburg, Germany.
- Kanngießer V Department of Surgery, Marburg University Hospital, 35043, Marburg, Germany.
- Zander T Department of Internal Medicine, University Hospital Köln, 50937, Köln, Germany.
- Alakus H Department of Surgery, University Hospital Köln, 50937, Köln, Germany.
- Hofheinz RD University Medical Center Mannheim, 68167, Mannheim, Germany.
- Roedel C Department of Radiation- Oncology, Frankfurt University Hospital, 60590, Frankfurt, Germany.
- Shah MA Department of Medicine Hematology and Oncology, Weill Cornell Medicine, New York, USA.
- Sasako M Department of Surgery, Hyogo College of Medicine, Mukogawa-cho, Nishinomiya, Hyogo, Japan.
- Lorenz D Department of General and Visceral Surgery, Sana- Klinikum Offenbach, 63069 Offenbach, Hamburg, Germany.
- Izbicki J Department of Surgery, Hamburg University Hospital, 20246, Hamburg, Germany.
- Bechstein WO Department of Surgery, Frankfurt University Hospital, 60590 Frankfurt, Hamburg, Germany.
- Lang H Department of Surgery, Mainz University Hospital, 55131, Mainz, Germany.
- Moenig SP Hôpitaux Universitaires de Genève, Service de Chirurgie viscéral, 1205, Genève, Switzerland.
- 2017-12-29
Published in:
- BMC cancer. - 2017
FLOT- regimen
Gastrectomy
Limited-metastatic disease
Localized peritoneal carcinomatosis
Metastatic gastric cancer
Metastatic gastroesophageal junction cancer
Oligometastatic cancer
Perioperative chemotherapy
Quality of life
Resection of metastases
Adenocarcinoma
Antineoplastic Combined Chemotherapy Protocols
Combined Modality Therapy
Esophageal Neoplasms
Esophagectomy
Esophagogastric Junction
Follow-Up Studies
Gastrectomy
Humans
Lymphatic Metastasis
Prognosis
Prospective Studies
Quality of Life
Stomach Neoplasms
Survival Rate
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s12885-017-3918-9
- PMID 29282088
- Persistent URL
- https://sonar.ch/global/documents/46505
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