The “RENAISSANCE” 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.

Authors

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Daniel Wilhelm Mueller

Institute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany

Daniel Wilhelm Mueller , Stefan Paul Moenig , Arndt Vogel , Sylvie Lorenzen , Nils Homann , Christoph Reissfelder , Claus Bolling , Wolfgang Blau , Wolff H. Schmiegel , Patrick Michl , Karel Caca , Matthias Schwarzbach , Ralf Hofheinz , Claus Roedel , Manish A. Shah , Mitsuru Sasako , Wolf O. Bechstein , Hauke Lang , Claudia Pauligk , Salah-Eddin Al-Batran

Organizations

Institute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany, Hôpitaux Universitaires de Genève, Service de Chirurgie viscéral, Geneva, Switzerland, Clinic of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany, Klinikum rechts der Isar der TU München, Munich, Germany, MED. Klinik II, Klinikum Wolfsburg, Wolfsburg, Germany, Department of Visceral, Thoracic, and Vascular Surgery, University Hospital Dresden, Dresden, Germany, Agaplesion Markus Hospital, Frankfurt, Germany, Universitaetsklinikum Giessen, Giessen, Germany, Ruhr-University Bochum, Bochum, Germany, Martin Luther University, Halle-Wittenberg, Halle, Germany, Klinikum Ludwigsburg, Ludwigsburg, Germany, Klinikum Frankfurt-Höchst, Department of Surgery, Frankfurt, Germany, University Medical Center Mannheim, Mannheim, Germany, Goethe University, Frankfurt, Germany, New York-Presbyterian Hospital, New York, NY, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan, Department of General and Visceral Surgery, University Hospital Frankfurt, Frankfurt, Germany, University Medical Center of the Johannes Gutenberg University, General, Visceral and Transplant Surgery, Mainz, Germany, Krankenhaus Nordwest, University Cancer Center, Frankfurt, Germany

Research Funding

Other Foundation

Background: Recent data indicates that surgical resection may bring a benefit for select patients with metastatic gastric / esophagogastric junction cancer. However, no data obtained in randomized trials is available up to now. The current RENAISSANCE trial investigates this long-lasting question about the role of surgical intervention in limited-metastatic gastric / esophagogastric junction cancer. Methods: This is a prospective, multicenter, randomized, investigator initiated phase III trial. In this study, 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) will receive 4 cycles of FLOT (docetaxel 50 mg/m²; oxaliplatin 85 mg/m²; leucovorin 200 mg/m²; 5-FU 2,600 mg/m²), and if Her2+ with trastuzumab. 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 be randomized. The primary endpoint is overall survival; main secondary endpoints are quality of life parameters as assessed by EORTC-QLQ-C30 questionnaire, progression free survival and surgical morbidity and mortality. Recruitment has already started; currently (Feb 2017) 21 patients have been enrolled. EudraCT: 2014-002665-30. Clinical trial information: NCT02578368

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT02578368

Citation

J Clin Oncol 35, 2017 (suppl; abstr TPS4140)

DOI

10.1200/JCO.2017.35.15_suppl.TPS4140

Abstract #

TPS4140

Poster Bd #

127b

Abstract Disclosures

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