The Mesothelioma and Radical surgery randomized controlled trial: the Mars feasibility study

Area of Science:

• Oncology
• Thoracic Surgery
• Clinical Trials

Background:

• Malignant pleural mesothelioma requires effective treatment strategies.
• Extrapleural pneumonectomy (EPP) is a radical surgical option.
• Its role in multimodality treatment needs validation through randomized controlled trials (RCTs).

Purpose of the Study:

• To determine the feasibility of randomizing patients with malignant pleural mesothelioma to either EPP or no surgery.
• To establish if a definitive RCT comparing EPP with non-surgical management is possible.

Main Methods:

• The Mesothelioma and Radical Surgery trial was designed as a feasibility study.
• It involved a two-stage consent process for 50 patients.
• Patients received platinum-based chemotherapy, followed by randomization to EPP plus radiotherapy or best supportive care.

Main Results:

• 112 patients entered the registration phase; 50 (45%) were ultimately randomized.
• Randomization occurred between EPP (24 patients) and continued best care (26 patients).
• Challenges included patient progression, inoperability, and withdrawals during the trial phases.

Conclusions:

• Randomizing patients with malignant pleural mesothelioma to EPP versus no surgery is feasible.
• This feasibility is a crucial step towards establishing EPP as a standard of care in a definitive RCT.
• The Mesothelioma and Radical Surgery trial successfully addressed its primary aim of demonstrating randomization feasibility.