A clinical trial that aims to determine whether taking daily aspirin can help to improve the survival rates of patients suffering from colorectal cancer, who have also had surgically-removed liver metastases, has now recruited its first patient.
The ASAC trial, a Scandinavian, multi-centre, double-blinded, randomised, placebo-controlled study, is funded by KLINBEFORSK (The Norwegian Department of Health and social Service’s programme for research on clinical treatments), The Norwegian Cancer Society, and The Research Council of Norway. It is the first randomised clinical trial that investigates the role of aspirin on survival rates of patients with colorectal liver metastases.
First patient recruited at Oslo University Hospital
The first patient was randomised at Oslo University Hospital (OUH) on Friday 15 December, meaning that the trial is now fully underway. Bjørn Atle Bjørnbeth, Head of hepatopancreatobiliary (HPB) Surgery at OUH is PI of the study, with NCMM Director Kjetil Taskén, and HPB surgeon Sheraz Yaqub at OUH as co-PIs.
The trial has also been approved by the Ethical and Medical Products Agency in Sweden, and all six sites in Sweden are now ready to start enrolling patients, with Danish sites will likely join the study and start recruitment in early 2018.
Aiming to recruit up to 800 patients to the trial
Up to 800 patients who have gone through surgery for liver metastases from colorectal cancer will be randomised to receive either 160 mg of aspirin once daily or a placebo, for a period of 3 years or until disease reoccurs. The patients will be treated and followed up according to standard of care and the National Guidelines.
Sheraz Yaqub, co-PI, comments:
“Aspirin is a very affordable and safe drug, which is easy to administer and which also comes without the side effects of many other secondary treatment options, such as chemotherapy. Aspirin is already widely used as a primary preventative measure for various health issues, but there is much debate over the potential risks it can cause.
“We have already in a register-based study shown the potential health benefit of aspirin in patients with colorectal cancer when it comes to survival. We feel that by studying its effects as a secondary prevention measure in a placebo-controlled randomised controlled trial, we can determine the true benefits of aspirin use more effectively than by studying it as a primary preventative measure.
"It’s very exciting to have recruited the first patient at the study’s lead site at Oslo University Hospital, and we look forward to more sites starting their recruitment process.” Sheraz Yaqub, co-PI.
The study will also look into molecular mechanisms of aspirin in disease prevention as well as determine the effect of aspirin as an adjuvant treatment on health-related quality of life and the cost-effectiveness.
Links to initial retrospective study on aspirin
The ASAC trial comes after an initial retrospective study, published in the Journal of Clinical Oncology, that looked back at the records of just over 23,000 patients diagnosed with CRC in Norway between 2004 and 2011. This study found that aspirin use in patients diagnosed with CRC helped to improve their survival rates.
The ASAC trial is initiated by Oslo University Hospital and University of Oslo, Norway. The study will be recruiting patients at five sites in Norway, six sites in Sweden and three sites Denmark. All of these sites are major HBP surgical units.
For more information about the study, visit the ASAC trial website or contact Sheraz Yaqub, Co-PI at Oslo University Hospital: shya@ous-hf.no