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Published in: Trials 1/2020

Open Access 01-12-2020 | Maintenance Therapy | Study protocol

ATLANTIS: a randomised multi-arm phase II biomarker-directed umbrella screening trial of maintenance targeted therapy after chemotherapy in patients with advanced or metastatic urothelial cancer

Authors: Ben Fulton, Robert Jones, Thomas Powles, Simon Crabb, James Paul, Alison Birtle, Simon Chowdhury, Syed Hussain, Anna Morris, Eileen Soulis, Paula Morrison

Published in: Trials | Issue 1/2020

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Abstract

Background

Metastatic urothelial cancer (UC) is the eighth most common cause of cancer death in the UK. Standard first-line treatment, for most patients, is cytotoxic chemotherapy. Although UC is initially sensitive to chemotherapy, relapse is almost inevitable and outcomes are poor; median overall survival is 8 months. Therefore, there is an urgent need for novel therapies to improve outcomes for this patient group.

Methods

ATLANTIS is a randomised phase II umbrella-design screening trial of maintenance therapy in biomarker-defined subgroups of patients with advanced UC. The primary end point is progression-free survival, and the study involves over 30 UK cancer centres.

Discussion

ATLANTIS is the first study in the UK to employ a precision-medicine approach to patients with UC for maintenance treatment. Agents with a positive efficacy signal will proceed to randomised phase III trials to confirm the activity of novel, biologically stratified therapies in UC.

Registration

ATLANTIS trial EudraCT number 2015–003249-25. ISRCTN25859465.
Appendix
Available only for authorised users
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Metadata
Title
ATLANTIS: a randomised multi-arm phase II biomarker-directed umbrella screening trial of maintenance targeted therapy after chemotherapy in patients with advanced or metastatic urothelial cancer
Authors
Ben Fulton
Robert Jones
Thomas Powles
Simon Crabb
James Paul
Alison Birtle
Simon Chowdhury
Syed Hussain
Anna Morris
Eileen Soulis
Paula Morrison
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04283-5

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