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.
Antineoplastic Agents
/ pharmacology
Antineoplastic Combined Chemotherapy Protocols
/ pharmacology
Biomarkers, Tumor
/ antagonists & inhibitors
Carcinoma, Transitional Cell
/ drug therapy
Humans
Mass Screening
/ methods
Molecular Targeted Therapy
/ methods
Multicenter Studies as Topic
Neoplasm Metastasis
/ drug therapy
Precision Medicine
/ methods
Progression-Free Survival
Randomized Controlled Trials as Topic
United Kingdom
/ epidemiology
Urologic Neoplasms
/ drug therapy
Biomarker
Precision medicine
Urothelial cancer
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
19 Apr 2020
19 Apr 2020
Historique:
received:
04
09
2019
accepted:
26
03
2020
entrez:
21
4
2020
pubmed:
21
4
2020
medline:
8
1
2021
Statut:
epublish
Résumé
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. 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. 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. ATLANTIS trial EudraCT number 2015-003249-25. ISRCTN25859465.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ATLANTIS trial EudraCT number 2015-003249-25. ISRCTN25859465.
Identifiants
pubmed: 32306987
doi: 10.1186/s13063-020-04283-5
pii: 10.1186/s13063-020-04283-5
pmc: PMC7168999
doi:
Substances chimiques
Antineoplastic Agents
0
Biomarkers, Tumor
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
344Subventions
Organisme : Cancer Research UK
ID : CTAAC Ref A18386
Pays : United Kingdom
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