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- W4226400086 abstract "Background: Metastatic urothelial cancer (MUC) is the eighth most common cause of cancer death in the UK. Chemotherapy is standard treatment for MUC. Although MUC is initially sensitive to chemotherapy, patients usually relapse within 6 months of completion. The outcome, once relapse has occurred, is very poor (median overall survival 8 months). Therefore, maintaining response to chemotherapy is an attractive goal, and a good environment for testing active single agents in MUC. ATLANTIS is a multi-arm, multi-stage signal searching trial. Patients will be allocated to treatment (vs observation or placebo where possible) based on biomarker expression. Design: ATLANTIS is a randomised phase II biomarker directed umbrella screening trial of maintenance therapy in biomarker defined subgroups of patients with advanced or metastatic urothelial cancer. The primary endpoint is progression-free survival. The protocol consists of a generic main section plus novel drug-specific appendices. The relevant novel drug-specific appendices will be amended when each specific subgroup trial completes or when a further novel drug subgroup is introduced. Central tissue screening for biomarker will occur prior to randomisation. Objectives: The trial will investigate whether maintenance targeted therapy after chemotherapy, with treatment selection based on biomarker expression, delays time to progression and overall survival for patients with MUC. Endpoints: Primary: To compare progression-free survival (PFS) of trial drug and placebo/observation. Different drugs will be tested in different biomarker defined subgroups in an adaptive design. PFS has been chosen as the primary end-point as it is largely objective (the majority of urothelial cancer patients will display progression in accordance with RECIST1.1 criteria) and clinically meaningful - progression after first line therapy represents the transition to the lethal stage of the disease and often the requirement for further cytotoxic therapy. Secondary: Overall survival, response rate, maximum percentage decrease in measurable disease, safety and tolerability. Exploratory: Progression free survival in subgroups defined by biomarkers other than those used for treatment allocation. Translational: Archival tissue, plasma and circulating tumor DNA will be stored and used for future research." @default.
- W4226400086 created "2022-05-05" @default.
- W4226400086 creator A5012800133 @default.
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- W4226400086 date "2022-04-05" @default.
- W4226400086 modified "2023-09-27" @default.
- W4226400086 title "ATLANTIS: An adaptive multi-arm phase II trial of maintenance targeted therapy after chemotherapy in advanced/metastatic urothelial cancer - Cabozantinib arm v1" @default.
- W4226400086 doi "https://doi.org/10.17504/protocols.io.81wgb6ro3lpk/v1" @default.
- W4226400086 hasPublicationYear "2022" @default.
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