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
| Autor: | Sylvie Lorenzen, Mitsuru Sasako, Wolfgang Blau, Stefan Paul Moenig, A. Wunsch, Karel Caca, Christoph Reissfelder, Frank Mannes, Patrick Michl, Claus Bolling, Thomas Jungbluth, Winfried Padberg, Christian Wilfried Scholz, Ralf Hofheinz, Salah-Eddin Al-Batran, Christoph Benckert, Harald Schmalenberg, Daniel Wilhelm Mueller, Thorsten Oliver Goetze, Alexander Novotny, Nils Homann, C. Roedel, Manish A. Shah, Hakan Alakus, Michael Winkler, Veit Kanngießer, Jorge Riera Knorrenschild, Karl-Hermann Fuchs, Steffen Retter, Claudia Pauligk, Arndt Vogel, Matthias Schwarzbach, Dietmar Lorenz, Michael Hohaus, Wolf O. Bechstein, Thomas Zander, Eva Horndasch, Michael Pohl, Jakob R. Izbicki, Hauke Lang, Julia Gumpp |
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| Rok vydání: | 2017 |
| Předmět: |
Cancer Research
Esophageal Neoplasms medicine.medical_treatment Adenocarcinoma / therapy law.invention Study Protocol 0302 clinical medicine Randomized controlled trial law Surgical oncology Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Prospective Studies Prospective cohort study Esophageal Neoplasms / pathology ddc:617 Esophageal Neoplasms / therapy lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens Prognosis Combined Modality Therapy Survival Rate Oncology Esophagectomy Lymphatic Metastasis 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Esophagogastric Junction Quality of life medicine.medical_specialty Esophageal Neoplasms / mortality Adenocarcinoma lcsh:RC254-282 Adenocarcinoma / mortality 03 medical and health sciences Resection of metastases Stomach Neoplasms Gastrectomy Antineoplastic Combined Chemotherapy Protocols / therapeutic use Genetics medicine Humans Progression-free survival Survival rate FLOT- regimen Esophagogastric Junction / pathology Perioperative chemotherapy business.industry Localized peritoneal carcinomatosis Adenocarcinoma / secondary Cancer Limited-metastatic disease medicine.disease Surgery Metastatic gastroesophageal junction cancer Esophagectomy / mortality Stomach Neoplasms / mortality Oligometastatic cancer Stomach Neoplasms / therapy Stomach Neoplasms / pathology business Metastatic gastric cancer Gastrectomy / mortality Follow-Up Studies |
| Zdroj: | BMC cancer, Vol. 17, No 1 (2017) P. 893 BMC Cancer BMC Cancer, Vol 17, Iss 1, Pp 1-7 (2017) |
| ISSN: | 1471-2407 |
| DOI: | 10.1186/s12885-017-3918-9 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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