Evidence map›Paper›PMID 29282088›Full record

Trial reportBMC cancer2017

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.

Salah-Eddin Al-Batran, Thorsten O Goetze, Daniel W Mueller, Arndt Vogel, Michael Winkler, Sylvie Lorenzen, Alexander Novotny, Claudia Pauligk, Nils Homann, Thomas Jungbluth and 31 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 116 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
116citing papers in PubMed, 6 pooled it
8.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02578368 phase3completednot on this map

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 Arbeitsgemeinschaft Internistische Onkologie/Chirurgische Arbeitsgemeinschaft Onkologie/Chirurgische Arbeitsgemeinschaft für Den Oberen Gastrointestinaltrakt (AIO/CAO-V/CAOGI)

TypeinterventionalSponsorKrankenhaus NordwestRan2016 to 2024Enrolled183ConditionsGastric CancerArms5-Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel, Trastuzumab
NCT06121700 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Radiotherapy, Chemotherapy and Anti-PD-1 Immunotherapy Followed by Surgical Resection in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single Arm, Phase II Trial

TypeinterventionalSponsorFudan UniversityRan2023 to 2027Enrolled55ConditionsAdenocarcinoma, Stomach Neoplasm, Gastroesophageal-junction Cancer, Oligometastatic DiseaseArmsRadiotherapy targeted to the primary lesion, Radiotherapy targeted to the metastatic lesions, Anti-PD-1 monoclonal antibody, Trastuzumab, Chemotherapy
3 · Its place in the literature

Who cites it

116 citing papers in PubMed, 6 syntheses or guidelines pooled it, 221 citations in OpenAlex.

  1. Gastric Carcinoma: Diagnosis, Staging, and Treatment.Deutsches Arzteblatt international · 2026
    Guideline
  2. Clinical practice guidelines for esophagogastric junction cancer: Upper GI Oncology Summit 2023.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2024
    Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Article
  8. Review
  9. Article
  10. Comparison of minimally invasive surgery and open surgery following chemotherapy for cStage IVb gastric cancer: a multicenter retrospective cohort study.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Article
  11. Prognosis-predicting factor of gastrectomy after systemic cancer therapy for cStage IVB gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Tackling similarities and differences in global practice guidelines for gastric cancer: a review on the latest Taiwan guidelines with Asia-Pacific, European and US guidelines.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Review
  17. Role of surgery in metastatic gastric cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  18. Review
  19. [Oligometastasis in the gastrointestinal tract].Chirurgie (Heidelberg, Germany) · 2026
    Article
  20. Review

56 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

41 authors at 20 institutions in 4 countries.

Salah-Eddin Al-BatranInstitute 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.
Thorsten O GoetzeInstitute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488, Frankfurt am Main, Germany.
Daniel W MuellerInstitute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488, Frankfurt am Main, Germany.
Arndt VogelDepartment of Internal Medicine, Hannover Medical School, 30625, Hannover, Germany.
Michael WinklerDepartment of Surgery, Hannover Medical School, 30625, Hannover, Germany.
Sylvie LorenzenDepartment of Internal Medicine, Klinikum rechts der Isar der TU München, 81675, Munich, Germany.
Alexander NovotnyDepartment of Surgery, Klinikum rechts der Isar der TU München, 81675, Munich, Germany.
Claudia PauligkInstitute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488, Frankfurt am Main, Germany.
Nils HomannDepartment of Internal Medicine II, Academic Teaching Hospital Wolfsburg, 05361, Wolfsburg, Germany.
Thomas JungbluthDepartment of Surgery, Academic Teaching Hospital Wolfsburg, 05361, Wolfsburg, Germany.
Christoph ReissfelderDepartment of Surgery, University Hospital Carl Gustav Carus Dresden, 01307, Dresden, Germany.
Karel CacaDepartment of Internal Medicine, Klinikum Ludwigsburg, 71640, Ludwigsburg, Germany.
Steffen RetterDepartment of Surgery, Klinikum Ludwigsburg, 71640, Ludwigsburg, Germany.
Eva HorndaschDepartment of Internal Medicine, Kliniken des Landkreises Neumarkt, 92318, Neumarkt, Germany.
Julia GumppDepartment of Surgery, Kliniken des Landkreises Neumarkt, 92318, Neumarkt, Germany.
Claus BollingDepartment of Internal Medicine, Agaplesion Markus Krankenhaus Frankfurter, Diakonie Kliniken gGmbH, 60431, Frankfurt, Germany.
Karl-Hermann FuchsDepartment of Surgery, Agaplesion Markus Krankenhaus Frankfurter Diakonie Kliniken gGmbH, 60431, Frankfurt, Germany.
Wolfgang BlauDepartment of Medical Oncology, Gießen University Hospital, 35392, Gießen, Germany.
Winfried PadbergDepartment of Surgery, Gießen University Hospital, 35392, Gießen, Germany.
Michael PohlDepartment of Internal Medicine, Ruhr-University Bochum, 44801, Bochum, Germany.
Andreas WunschDepartment of Surgery, Ruhr-University Bochum, 44801, Bochum, Germany.
Patrick MichlDepartment of Medical Oncology, Halle University Hospital, 06120, Halle (Saale), Germany.
Frank MannesDepartment of Internal Medicine, Halle University Hospital, (Saale), 06120, Halle, Germany.
Matthias SchwarzbachDepartment of Surgery, Klinikum Frankfurt Höchst, 65929, Frankfurt, Germany.
Harald SchmalenbergDepartment of Internal Medicine IV, Städtisches Klinikum Dresden, 01067, Dresden, Germany.
Michael HohausDepartment of Surgery, Städtisches Klinikum Dresden, 01067, Dresden, Germany.
Christian ScholzDepartment of Medical Oncology, Vivantes Klinikum Am Urban Berlin, 10967, Berlin, Germany.
Christoph BenckertDepartment of Surgery, Vivantes Klinikum Am Urban Berlin, 10967, Berlin, Germany.
Jorge Riera KnorrenschildDepartment of Medical Oncology, Marburg University Hospital, 35043, Marburg, Germany.
Veit KanngießerDepartment of Surgery, Marburg University Hospital, 35043, Marburg, Germany.
Thomas ZanderDepartment of Internal Medicine, University Hospital Köln, 50937, Köln, Germany.
Hakan AlakusDepartment of Surgery, University Hospital Köln, 50937, Köln, Germany.
Ralf-Dieter HofheinzUniversity Medical Center Mannheim, 68167, Mannheim, Germany.
Claus RoedelDepartment of Radiation- Oncology, Frankfurt University Hospital, 60590, Frankfurt, Germany.
Manish A ShahDepartment of Medicine Hematology and Oncology, Weill Cornell Medicine, New York, USA.
Mitsuru SasakoDepartment of Surgery, Hyogo College of Medicine, Mukogawa-cho, Nishinomiya, Hyogo, Japan.
Dietmar LorenzDepartment of General and Visceral Surgery, Sana- Klinikum Offenbach, 63069 Offenbach, Hamburg, Germany.
Jakob IzbickiDepartment of Surgery, Hamburg University Hospital, 20246, Hamburg, Germany.
Wolf O BechsteinDepartment of Surgery, Frankfurt University Hospital, 60590 Frankfurt, Hamburg, Germany.
Hauke LangDepartment of Surgery, Mainz University Hospital, 55131, Mainz, Germany.
Stefan P MoenigHôpitaux Universitaires de Genève, Service de Chirurgie viscéral, 1205, Genève, Switzerland.
University Hospital Frankfurt · DEFraunhofer Project Centre Wolfsburg · DEKliniken des Landkreises Lörrach · DEKlinikum Ludwigsburg · DEKlinikum rechts der Isar · DEMedizinische Hochschule Hannover · DEPhilipps University of Marburg · DERuhr University Bochum · DEStädtisches Klinikum Dresden · DEUniversity Hospital in Halle · DEVivantes Klinikum · DEAgaplesion Frankfurter Diakonie Kliniken · DEAgaplesion Markus Hospital · DEHôpital Beau-Séjour · CHHyogo Medical University · JPInstitute of Clinical Cancer Research · DEJohannes Gutenberg University Mainz · DEKlinikum Frankfurt Höchst · DEKrankenhaus Nordwest · DESana Klinikum Offenbach · DE

Funding

Deutsche Forschungsgemeinschaft AL 1817/1-1
6 · The paper itself

Abstract

backgroundHistorical 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.

methodsThis 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 registrationThe 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.

Indexed as

Quality of LifeAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyEsophageal NeoplasmsEsophagectomyEsophagogastric JunctionFollow-Up StudiesGastrectomyHumansLymphatic MetastasisPrognosisProspective StudiesStomach NeoplasmsSurvival RateFLOT- regimenGastrectomyLimited-metastatic diseaseLocalized peritoneal carcinomatosisMetastatic gastric cancerMetastatic gastroesophageal junction cancerOligometastatic cancerPerioperative chemotherapyQuality of lifeResection of metastases

Identifiers

PMID29282088
PMCPMC5745860
OpenAlexW2777030709

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.