ATLANTIS
Research type
Research Study
Full title
An adaptive multi-arm phase II trial of maintenance targeted therapy after chemotherapy in metastatic urothelial cancer.
IRAS ID
186191
Contact name
Eileen Soulis
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Eudract number
2015-003249-25
ISRCTN Number
ISRCTN25859465
Duration of Study in the UK
7 years, 6 months, 0 days
Research summary
Metastatic urothelial cancer (MUC), including bladder and upper urinary tract cancers, is the eighth most common cause of cancer death in the UK. The standard treatment for MUC is chemotherapy, given for a defined period of time (often 2-4 months), to control the tumour and maintain a good quality of life for as long as possible. After completion of chemotherapy, the cancer would start to grow again and may spread to other parts of the body, often referred to as ‘relapse’ of the cancer. The outcome once relapse has occurred is very poor, with average life expectancy around 8 months.
Patients will have trial treatment selected based on the presence or not of particular molecules (biological markers/biomarkers) in their cancer tissue. Depending on which ‘biomarkers’ are present within the cancer, the patient will be matched to a drug subgroup in the main trial. Patients will be randomly allocated to the trial treatment or placebo (non-active tablet). ATLANTIS will investigate whether treatment matched to the biomarker given after initial chemotherapy delays the time to the cancer growing in patients with MUC.
The target population includes patients with cancer affecting the bladder, including upper urinary tract which has spread elsewhere (metastatic) and is usually treated with chemotherapy. Patients in the study must have had chemotherapy (between 4-8 cycles) and their cancer should have responded or not worsened during this period. The testing for tumour biomarkers will be done on tissue removed at the time of the original cancer diagnosis.
Patients will continue to receive trial treatment until their cancer worsens, they have significant side effects, are recommended to start further anti-cancer therapy, patient withdraws consent or if it is no longer in the best interests of the patient to continue with the trial treatment. Patients will be followed up for information on further anti-cancer treatments they receive after stopping trial therapy as well as information about how long patients survive after the trial.
REC name
West of Scotland REC 1
REC reference
16/WS/0197
Date of REC Opinion
28 Nov 2016
REC opinion
Further Information Favourable Opinion