Spots Global Cancer Trial Database for Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence
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Trial Identification
Brief Title: Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence
Official Title: Adjuvant Immunotherapy in Patients With Resected Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): an Open Label Randomized Controlled Phase-2-study
Study ID: NCT03443856
Study Description
Brief Summary: The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection. Other study objectives: * To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study * To correlate nutritional status assessment on outcomes and quality of life of patients
Detailed Description:
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Masaryk Memorial Cancer Institute, Brno, , Czechia
University Hospital Hradec Kralove, Hradec Králové, , Czechia
CHRU de Lille - Hopital Huriez, Lille, , France
Hôpital Privé Jean Mermoz, Lyon, , France
Gustave Roussy, Villejuif, , France
Charite - Universitaetsmedizin Berlin, Berlin, , Germany
Kliniken Essen-Mitte, Essen, , Germany
Universitaetsklinikum Freiburg, Freiburg, , Germany
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center, Hamburg, , Germany
SLK-Kliniken Heilbronn, Heilbronn, , Germany
Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden, Leipzig, , Germany
Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar, München, , Germany
Universitaetsklinikum Tuebingen-Uni Kliniken Berg, Tuebingen, , Germany
Rambam Health Care Campus, Oncology Institute, Haifa, , Israel
Rabbin Medical Centre - Tel Aviv, Tel Aviv, , Israel
Azienda Ospedaliera a Papa Giovanni XXIII, Bergamo, , Italy
Istituto Europeo di Oncologia, Milan, , Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Napoli, , Italy
Oslo University Hospital - Ullevaal Hospital, Oslo, , Norway
Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw, , Poland
Institut Catalan d'Oncologia - ICO Badalona, Badalona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Complejo Hospitalario A, Pamplona, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Cambridge University Hospital NHS, Cambridge, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Contact Details
Name: Florian Lordick
Affiliation: Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden, Leipzig, Germany
Role: STUDY_CHAIR
Name: Maren Knoedler
Affiliation: Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden, Leipzig, Germany
Role: STUDY_CHAIR
Name: Elizabeth Smyth
Affiliation: Cambridge University Hospital NHS - Cambridge, UK
Role: STUDY_CHAIR
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