Rectal cancer trial recruitment close to completion

Thursday 16th November 2017

Recruitment is almost complete for a clinical trial into a new treatment for advanced rectal cancer. The trial – called ARISTOTLE – is testing the benefits of adding a second drug, called irinotecan, to the standard treatment for the disease.

ARISTOTLE is a Phase III trial – used to compare new treatments with the best available standard treatment – which is beyond the remit of the Leeds CRF, but the Facility is involved in an experimental aspect of the study. This is looking at whether biomarkers in blood and tissue samples could replace scans to predict how well patients are responding to treatment.

Irinotecan is already widely used to treat many cancers, but researchers want to find out if combining it with the chemotherapy drug capectabine and radiotherapy to treat locally advanced rectal cancer will help to prevent the cancer coming back following surgery.

The standard treatment for the disease involves combining capectabine with radiotherapy to shrink the tumour prior to surgery. However, as chemoradiotherapy is not always effective, patients are also regularly scanned in the weeks before surgery to monitor the tumour’s size.

Patients on the experimental arm of the study will have blood samples taken prior to treatment and then three times in the weeks leading up to surgery. The samples will be tested for genetic and other markers to see if these can be correlated to how well the patients responded to the treatment, to reduce the need for expensive and invasive scans in the future.

Over 550 patients have been recruited to the Cancer Research UK-funded trial, with 50 more to be recruited to meet the target. More than 100 sites are taking part and most of these are also involved in the biomarker study.

The trial is being led by Professor David Sebag-Montefiore who heads the radiotherapy research group at the University of Leeds. Leeds has recently been assessed as an emerging Centre of Excellence in radiotherapy research, by the Clinical and Translational Radiotherapy Research Working Group of the National Cancer Research Institute.

“It is very important that we find ways to improve the treatment of rectal cancer,” said Professor Sebag-Montefiore. “As well as testing the addition of a second drug we need ‘smarter’ ways of working out if new treatments are working in patients. We need more translational research studies such as the approach used in ARISTOTLE to help us achieve this aim.  We are very pleased that patients have been happy to help us collect these blood samples in ARISTOTLE using the CRFs in the recruiting hospitals.

“Although recruitment for ARISTOTLE is now coming to its conclusion, we have many more trials in the pipeline where we’ll be working with the Leeds CRF to deliver this aspect of the research.”