After almost seven years, and with the involvement of over 100 centres from across the UK, the CTC’s ARISTOTLE trial has closed to recruitment.
Patients who have joined the study have a type of rectal cancer which has spread into surrounding tissues. ARISTOTLE is the only phase III trial in the world looking to find out whether adding a chemotherapy drug called irinotecan to their standard treatment will stop or help to delay the return of their cancer following surgery.
Treatment for these patients currently involves a chemotherapy drug called capecitabine combined with radiotherapy, but the chances of the disease not returning within three years are relatively poor. Researchers want to find out more about the potential benefits of adding irinotecan, as well as its side effects.
Despite targeting a very specific type of cancer in this way (more details on which can be read here), the trial has still managed to recruit 589 patients from seventy-five centres from across the UK. In total, 101 centres actively participated in various aspects of the trial, including screening, recruitment, treatment, follow-up and pathology.
Trial coordinator Rubina Begum remarked: ‘This trial could not have been done without the outstanding cooperation and support of all centres involved, nor without the commitment of the participating patients and their families.’
She added: ‘We have also collected a large number of tumour blocks and bloods samples from ARISTOTLE patients. Research using these samples may help us to match future patients with treatments that are effective but have less risk of severe side effects, or by identifying predictive and prognostic biomarkers that may offer early assessment of response and relapse in standard treatment combinations. This opens up the possibility of personalising treatment.’
ARISTOTLE chief investigator, Prof David Sebag-Montefiore, said: ‘It has been a real joint effort and we are so grateful that we have successfully recruited so close to our 600 target. This is so important for all of the patients who kindly agreed to participate in the study and we are well placed to answer the key questions that ARISTOTLE is designed to answer.
‘I would like to extend a very big thank you to all of the ARISTOTLE teams around the country. We are so grateful for your support and commitment to the trial. We recognise that sites face many challenges in maintaining their portfolio, and your commitment to ARISTOTLE has been excellent’.
The results of the trial are expected to be available around the end of 2022.
Further details on the trial can be found here.