Mesothelioma and Radical Surgery 2 (MARS 2): protocol for a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decortication for patients with malignant pleural mesothelioma

Abstract

IntroductionMesothelioma remains a lethal cancer. To date, systemic therapy with pemetrexed and a platinum drug remains the only licensed standard of care. As the median survival for patients with mesothelioma is 12.1 months, surgery is an important consideration to improve survival and/or quality of life. Currently, only two surgical trials have been performed which found that neither extensive (extra-pleural pneumonectomy) or limited (partial pleurectomy) surgery improved survival (although there was some evidence of improved quality of life). Therefore, clinicians are now looking to evaluate pleurectomy decortication, the only radical treatment option left.Methods and analysisThe MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery—(extended) pleurectomy decortication—versus no surgery for the treatment of pleural mesothelioma. The study will test the hypothesis that surgery and chemotherapy is superior to chemotherapy alone with respect to overall survival. Secondary outcomes include health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.Ethics and disseminationResearch ethics approval was granted by London – Camberwell St. Giles Research Ethics Committee (reference 13/LO/1481) on 7 November 2013. We will submit the results for publication in a peer-reviewed journal.Trial registration numbersISRCTN—ISRCTN44351742 and ClinicalTrials.gov—NCT02040272.

Role of induction and adjuvant systemic treatment in mesothelioma: narrative review

“…The Mesothelioma and Radical Surgery 2 trial (MARS-2) is an ongoing study in the United Kingdom that evaluates the role of surgery (P/D) followed by chemotherapy with chemotherapy alone. This is an unusual and challenging trial design that recognizes the uncertain role of surgery in this disease (23). The planned enrollment for the trial is 328, which will make it by far the largest prospective study of multimodality therapy in this disease.…”

Use of preclinical models for malignant pleural mesothelioma

“… 16 The benefit of open pleurectomy/decortication in addition to chemotherapy is currently under investigation in the MARS 2 trial. 17 The MesoVATS trial previously showed that a video-assisted thoracoscopic partial pleurectomy does not improve overall survival of patients. 18 At present, the benefits of surgery in MPM remains limited.…”

Commentary: Extended pleurectomy decortication: Step 1, standardized techniques; step 2, standardized documentation

“…Efforts for surgical standardization have already started in the MARS 2 trial, and we await the results. 2 That's why the article by Ripley and Palivela in this issue of JTCVS Techniques . The authors have taken all the pearls not only from their own substantial experience but also from the literature to provide both EPD veterans and rising mesothelioma surgeons with a mental checklist to be crossed off during the procedure.…”