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Mesothelioma and Radical Surgery 2 (MARS2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02040272
Recruitment Status : Recruiting
First Posted : January 20, 2014
Last Update Posted : October 30, 2019
Sponsor:
Collaborators:
University of Bristol
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:

Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2500 people in the UK are diagnosed with mesothelioma each year and the median survival is approximately 8.5 months. Exposure to asbestos is the most common cause although the cancer does not usually become apparent until 40-60 years after exposure. Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) is undertaken. However, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients. The aim of the MARS2 study is to compare surgery - (extended) pleurectomy decortication - with no surgery with respect to overall survival, cost-effectiveness and quality of life. Patients will be followed up by phone at regular intervals for 2 years. Patients will be asked to complete and return a Quality of Life Questionnaire at these time points.

MARS 2 also includes an optional 'Information study', where consenting patients may be interviewed or have their consultations audio-recorded. The aim of the Information study is to explore how a patient makes a decision to take part in research or not, with the overall aim of improving recruitment to clinical trials.


Condition or disease Intervention/treatment Phase
Mesothelioma Procedure: (Extended) pleurectomy decortication Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesothelioma and Radical Surgery 2: a Multicentre Randomised Trial Comparing (Extended) Pleurectomy Decortication Versus no (Extended) Pleurectomy Decortication for Patients With Malignant Pleural Mesothelioma (Mars 2).
Study Start Date : May 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: Surgery
(Extended) pleurectomy decortication
Procedure: (Extended) pleurectomy decortication
No Intervention: no surgery
no surgery



Primary Outcome Measures :
  1. Survival [ Time Frame: 24 months ]
    The time from randomisation to death will be measured and date of death will be collected on purposely designed case report forms.


Secondary Outcome Measures :
  1. Progression free survival to two years [ Time Frame: 24 months ]
  2. Serious adverse health events to two years after randomisation [ Time Frame: 24 months ]
  3. Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years [ Time Frame: 24 months ]
    • 3 types of scales. Functioning scales which include physical functioning, role functioning, emotional function, cognitive functioning and social functioning. Symptom scales which include fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties. An overall global health status/QoL
    • All scales range between 0 and 100.
    • For functioning scales, a high score indicates a high level of functioning. Similarly, a high global health status/QoL score indicates a high quality of life. For symptom scales, a high score indicates a high level of symptoms.

  4. Resource and health service use to two years and during initial surgical admission for surgical arm [ Time Frame: 24 months and during initial surgical admission for surgical arm ]
  5. Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years [ Time Frame: 24 Months ]
    • subscales: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. These range from 1-5.
    • subscales mobility, self-care, usual activities, pain/discomfort, anxiety/depression are combined to calculate an overall index score which ranges from -0.59 to 1.
    • A higher score indicates better quality of life

  6. Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years [ Time Frame: 24 months ]
    • VAS (visual analogue scale) score. Ranges from 0 to 100.
    • A higher score indicates better quality of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. 16 years of age or over
  2. Tissue (cytology or histology) confirmed epithelioid, sarcomatoid or biphasic mesothelioma
  3. Disease confined to one hemi-thorax based on CT assessment
  4. Disease deemed surgically resectable
  5. Fit for surgery
  6. Capacity to provide written informed consent to participate in the trial

Exclusion criteria:

  1. Severe shortness of breath (this is defined as an Eastern Cooperative Oncology Group (ECOG) status ≥ 2, or if lung function tests are performed: pre-operative forced expiratory volume after one second (FEV1) or transfer factor of the lung for carbon monoxide (TLco) less than 20%)
  2. Serious concomitant disorder that would compromise participant safety during surgery (e.g. evidence of end organ failure)
  3. Severe heart failure (this is defined as NYHA III or IV or if an echocardiogram is performed an ejection fraction less than 30%)
  4. End stage kidney failure requiring dialysis
  5. Liver failure (e.g. encephalopathy and/or coagulation abnormalities)
  6. Prisoner
  7. Patient lacks capacity to consent
  8. Existing co-enrolment in another interventional clinical trial that aims to improve survival

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040272


Contacts
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Contact: Eric Lim e.lim@rbht.nhs.uk
Contact: Study Mailbox Mars2-trial@bristol.ac.uk

Locations
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Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
University of Bristol
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Eric Lim Royal Brompton & Harefield NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02040272    
Other Study ID Numbers: MARS2
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial