VESTIGE: Adjuvant Immunotherapy in Patients With Resected Esophageal, Gastroesophageal Junction and Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): An Open Label Randomized Controlled Phase-2-Study.

Details

Serval ID
serval:BIB_3144C154E1E3
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
VESTIGE: Adjuvant Immunotherapy in Patients With Resected Esophageal, Gastroesophageal Junction and Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): An Open Label Randomized Controlled Phase-2-Study.
Journal
Frontiers in oncology
Author(s)
Smyth E., Knödler M., Giraut A., Mauer M., Nilsson M., Van Grieken N., Wagner A.D., Moehler M., Lordick F.
ISSN
2234-943X (Print)
ISSN-L
2234-943X
Publication state
Published
Issued date
2019
Peer-reviewed
Oui
Volume
9
Pages
1320
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
Background: Perioperative chemotherapy plus surgery is one recommended standard treatment for patients with resectable gastric and esophageal cancer. Even with a multimodality treatment more than half of patients will relapse following surgical resection. Patients who have a poor response to neoadjuvant chemotherapy and have an incomplete (R1) resection or have metastatic lymph nodes in the resection specimen (N+) are especially at risk of recurrence. Current clinical practice is to continue with the same chemotherapy in the adjuvant setting as before surgery. In the phase II randomized EORTC VESTIGE trial (NCT03443856), patients with high risk resected gastric or esophageal adenocarcinoma will be randomized to either adjuvant chemotherapy (as before surgery) or to immunotherapy with nivolumab and low dose ipilimumab (nivolumab 3 mg/kg IV Q2W plus Ipilimumab 1 mg/kg IV Q6W for 1 year). The primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life. This is an open label randomized controlled multi-center phase-2 superiority trial. Patients will be randomized in a 1:1 ratio to study arms. The trial will recruit 240 patients; recruitment commenced July 2019 and is anticipated to take 30 months. Detailed inclusion/exclusion criteria, toxicity management guidelines, and statistical plans for EORTC VESTIGE are described in the manuscript. Clinical Trial Registration: The trial is registered with www.ClinicalTrials.gov, identifier: NCT03443856.
Keywords
adjuvant, chemotherapy, gastric cancer, gastroesophageal cancer, immunotherapy, ipilimumab, nivolumab, perioperative
Pubmed
Open Access
Yes
Create date
27/02/2020 15:45
Last modification date
26/11/2020 6:26
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