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Fig. 2 | Trials

Fig. 2

From: 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

Fig. 2

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure: Schedule of Assessments for ATLANTIS trial. (1) Patients should have signed and dated informed consent forms for pre-screening. (2) Each patient must have signed and dated both informed consent forms for pre-screening biomarker testing and full trial screening before engaging in any trial-related procedures. All screening evaluations must be completed before the patient is randomly assigned to receive trial drug or placebo. (3) Patient characteristics will be collected at pre-screening. These data should be collected only if they are available from data collection during the previous 6 weeks as part of standard care. No additional blood tests should be performed during pre-screening purely for the trial. (4) Tumour samples and all other translational samples should be sent to the attention of Charlotte Ackerman for centralised pre-screening or confirmation. If there is any tissue left from biomarker testing, it will be stored in the Orchid Tissue Bank for future translational research. Individual samples will be returned at the end of the trial on request. Samples will be processed in accordance with the ATLANTIS lab manual. (5) Weight, height, pulse and blood pressure. (6) Human chorionic gonadotropin (HCG) results must be obtained and reviewed before the first dose of Investigational Medicinal Product (IMP) is administered for women of child-bearing potential. (7) Haematology, including full blood count with white blood cell count, absolute neutrophil count, platelet count and haemoglobin. Biochemistry, including sodium, potassium, aspartate aminotransferase/alanine aminotransferase (AST/ALT), alkaline phosphatise, lactate dehydrogenase, bilirubin, creatinine, protein and albumin. (8) All patients should have abdominal and pelvic computed tomography (CT) or magnetic resonance imaging (MRI) plus either chest x-ray (postero-anterior and lateral views) or chest CT scan. If known or thoracic metastases are seen on chest x-ray, patients must have a thoracic CT scan. Patients should have baseline scanning every 12 weeks until week 49; following this, scans should be carried out at the discretion of the individual clinician. (9) Patients who come off the trial should have tumour assessments within 4 weeks of coming off trial drug/placebo, irrespective of whether the patient is still being followed up for progression. (10) Patients who come off the trial should have tumour measurements where they have not been completed within the past 4 weeks. This includes abdominal and pelvic CT or MRI plus either chest x-ray (postero-anterior and lateral views) or chest CT scan. If known or thoracic metastases are seen on chest x-ray, patients must have a thoracic CT scan. Patients who stop treatment for whatever reason before progressive disease is documented will continue to have scans at 12-weekly intervals as previously. (11) Follow-up visits after progression will continue at the investigators’ discretion until death. Future treatment and cause of death must be recorded on the case report form. (12) Frequency of treatment visits will vary within the different treatment arms; please see individual IMP drug appendices for this information. Abbreviations: ECG electrocardiogram, GFR glomerular filtration rate, WHO World Health Organization

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