MARS 2 is the world's only multicentre randomised clinical trial to evaluate the feasibility of recruiting into a trial of surgery for malignant pleural mesothelioma.
2016 has certainly been an exciting year for the trial as we achieved both feasibility endpoints which is the ability to randomise 25 patients in any 6 months or 50 patients within 24 months. As of the 5 December 2016 (during the World Conference of Lung Cancer) the 50th participant was randomised 5 months ahead of schedule allowing us to declare the trial "feasible"!
In 2017, MARS 2 will proceed to the full trial that seeks to randomise 326 patients in total to determine the impact of the currently most commonly performed operation (extended pleurectomy decortication) on overall survival.
This is when the real work begins, as we have applied to the UK NIHR for a grant to support the full trial and we will need to open more medical and surgical centres to support the additional numbers required to complete the trial. In addition, we intend to use Quintet Recruitment Intervention methods developed by the University of Bristol to ensure that we can and will continue to recruit well so that we will complete the trial to time (3 more years of recruitment and 2 more years of follow up). We are certainly looking for more high volume medical centres but probably fewer surgical centres) to recruit the remaining 280 randomised participants. The rationale is that we need a good base to feed into the trial (medical centres) but also a good volume of operations in selected surgical centres to maintain quality assurance of surgery. Given that a further 140 participants will be randomised to surgery over three years is approximately 46 surgical procedures per year. If 4 centres were to do the work, then each centre operates on approximately 12 participants per year (essentially 1 per month).
We are grateful to the hard work of our trials centres, trial governance, trial management teams for all their hard work and to all the patients who strongly supported the feasibility component to allow us to research this stage!
MARS 2 would not be possible without the support of CRUK and generously assisted by contributions from Mesobank, Irwin Mitchell Solicitors and June Hancock Mesothelioma Research Fund.