{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2023"],"condition":["Locally advanced rectal cancer"],"data_sharing_plan":["De-identified individual participant data datasets generated and/or analysed during the current study will be available upon request from the Clinical Trials Research Unit, University of Leeds (contact CTRU-DataAccess@leeds.ac.uk in the first instance). Data will be made available at the end of the trial, i.e. usually when all primary and secondary endpoints have been met and all key analyses are complete. Data will remain available from then on for as long as CTRU retains the data.\nCTRU makes data available by a ‘controlled access’ approach. Data will only be released for legitimate secondary research purposes, where the Chief Investigator, Sponsor and CTRU agree that the proposed use has scientific value and will be carried out to a high standard (in terms of scientific rigour and information governance and security), and that there are resources available to satisfy the request. Data will only be released in line with participants’ consent, all applicable laws relating to data protection and confidentiality, and any contractual obligations to which the CTRU is subject. No individual participant data will be released before an appropriate agreement is in place setting out the conditions of release. The agreement will govern data retention, usually stipulating that data recipients must delete their copy of the released data at the end of the planned project.\nThe CTRU encourages a collaborative approach to data sharing and believes it is best practice for researchers who generated datasets to be involved in subsequent uses of those datasets. Recipients of trial data for secondary research will also receive data dictionaries, copies of key trial documents and any other information required to understand and reuse the released datasets.\nThe conditions of release for aggregate data may differ from those applying to individual participant data. Requests for aggregate data should also be sent to the above email address to discuss and agree on suitable requirements for release.\nIPD policy summary: Available on request"],"disease":["Locally Advanced Rectal Cancer"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/110232"],"location":["United Kingdom"],"study_start_month":["1"],"keyword":["AN0025"],"repository":["ECRIN MDR"],"study_status":["Not yet recruiting"],"additional_accession":[]},"is_claimable":false,"name":"The ARTEMIS trial is for patients who have been diagnosed as having a cancer of the lower bowel, known as the rectum. This study will examine the benefit of adding an additional treatment alongside radiotherapy and chemotherapy with the hope of increasing the chance of curing rectal cancer without the need for surgery.","description":"Background and study aims\nRadiotherapy (RT) based treatment for patients with localised rectal cancer can result in long-term cure of the disease, enabling patients to avoid surgery to remove parts of the rectum (known as ‘organ preservation’ (OP)). Based on our own patient survey, OP is one of the main concerns of the patient population, though with current treatments available it is not an outcome that is available to most patients. Improving OP rate is an important priority of the trial. There is research showing encouraging results when immunotherapy is used in combination with RT treatment. To this end, the trial aims to test the efficacy of a new immunotherapy drug ‘AN0025’. Research has shown that it could be an effective treatment which allows patients a better quality of life (QoL). The trial aims to compare what would, effectively, be ‘standard care’ for patients and ‘standard care’ in combination with AN0025. There is evidence for the benefits of immunotherapy when treating localised rectal cancer, further research is required as: there is a lack of data relating to OP, new drugs and treatments that may increase rates of OP need to be evaluated, there is little information on health-related QoL and how patients experience treatment and more data is needed to better design methods of assigning patients to treatments that best suit them. \nWho can participate?\nThe trial will be conducted at approximately 15-20 NHS sites in the UK and open to all adults in the patient population (140 patients, 70 patients in each arm).\nWhat does the study involve?\nPatients will undergo a regime of either LCCRT or SCRT (dependant on clinician choice) that will take 1-5 weeks, followed by 12 weeks of chemotherapy (this combination is referred to as ‘total neoadjuvant therapy’). Patients on the experimental arm will begin taking AN0025 prior to beginning their RT and will stop when their chemotherapy ends. Both arms will then be followed up at 4, 6, 9, 12, 18, 24 and 30 months (post-start of RT) where they will attend clinic and perform assessments.","dates":{"creation":"2023-01-15"},"accession":"110232","cross_references":{"EU Clinical Trials Register":["2021-005716-57"],"ISRCTN":["ISRCTN15384496"]}}