Randomized controlled trial of S-1 maintenance therapy in metastatic esophagogastric cancer – the multinational MATEO study

BMC Cancer

Study Protocol

Georg-Martin Haag¹  Dirk Jaeger¹  Julia Quidde²  Florian Lordick³  Gertraud Stocker³ 

[1] Department of Medical Oncology, National Center for Tumor Diseases, University Hospital Heidelberg, Im Neuenheimer Feld 460, D-69120, Heidelberg, Germany;II. Department of Internal Medicine (Oncology/Haematology), University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany;University Cancer Center Leipzig (UCCL), University Hospital Leipzig, Liebigstrasse 20, D–04103, Leipzig, Germany;

关键词: Gastric cancer;    Esophagogastric cancer;    Adenocarcinoma;    S-1;    Chemotherapy;    Maintenance therapy;   

DOI  :  10.1186/s12885-017-3497-9

 received in 2016-10-20, accepted in 2017-07-23,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThe optimal duration of firstline chemotherapy in metastatic esophagogastric cancer is unknown. In most clinical trials therapy was given until tumour progression or limiting toxicity. Maintenance concepts aiming to prolong the duration of response and maintain quality of life have been established in other tumour types but not in esophagogastric cancer. S-1 is an oral fluoropyrimidine with proven efficacy in metastatic esophagogastric cancer.MethodsThe Maintenance Teysuno® (S-1) in esophagogastric cancer (MATEO) trial is a multinational, randomized phase II study that explores the role of S-1 maintenance therapy in Her-2 negative, advanced esophagogastric adenocarcinoma. After a 12-week firstline platinum-fluoropyrimidine-based chemotherapy patients without tumour progression are randomized in a 2:1 allocation to receive S-1 alone or continue with the same regimen as during the primary period. The primary endpoint is overall survival. Secondary endpoints include safety and toxicity, progression-free survival and quality of life.Correlative biomarker analyses focus on the identification of a subgroup of patients with a prolonged benefit from S-1 based maintenance therapy.DiscussionMATEO will be the first trial to define the role of a S-1 based maintenance therapy in patients having received a platinum-based firstline chemotherapy.Trial registrationNCT02128243 (date of registration: 29–04-2014).

【 授权许可】

CC BY   
© The Author(s). 2017