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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

Published inBMC cancer, vol. 17, no. 1, 893
Publication date2017-12-28
First online date2017-12-28
Abstract

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. outcome is negative, patients with gastric or GEJ cancer and metastases will no longer be considered candidates for surgical intervention.

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Keywords
  • 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 / mortality
  • Adenocarcinoma / secondary
  • Adenocarcinoma / therapy
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Combined Modality Therapy
  • Esophageal Neoplasms / mortality
  • Esophageal Neoplasms / pathology
  • Esophageal Neoplasms / therapy
  • Esophagectomy / mortality
  • Esophagogastric Junction / pathology
  • Follow-Up Studies
  • Gastrectomy / mortality
  • Humans
  • Lymphatic Metastasis
  • Prognosis
  • Prospective Studies
  • Quality of Life
  • Stomach Neoplasms / mortality
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / therapy
  • Survival Rate
Citation (ISO format)
AL-BATRAN, Salah-Eddin et al. 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. In: BMC cancer, 2017, vol. 17, n° 1, p. 893. doi: 10.1186/s12885-017-3918-9
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Article (Published version)
Identifiers
ISSN of the journal1471-2407
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