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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

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE January 20, 2014
Last Update Posted Date October 30, 2019
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
Ability to randomise 50 patients [ Time Frame: 24 months ]
Ability to randomise 50 patients within the first 24 months or the ability to recruit 25 patients within any 6 month period
Change History Complete list of historical versions of study NCT02040272 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Progression free survival to two years [ Time Frame: 24 months ]
  • Serious adverse health events to two years after randomisation [ Time Frame: 24 months ]
  • 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.
  • 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 ]
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
  • Survival from the time point of randomisation [ Time Frame: Follow up for up to 5 years ]
  • Quality of life as assessed using QLQ 30 and LC-13 scales [ Time Frame: Follow up for up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesothelioma and Radical Surgery 2
Official Title  ICMJE 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).
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mesothelioma
Intervention  ICMJE Procedure: (Extended) pleurectomy decortication
Study Arms  ICMJE
  • Experimental: Surgery
    (Extended) pleurectomy decortication
    Intervention: Procedure: (Extended) pleurectomy decortication
  • No Intervention: no surgery
    no surgery
Publications * Warnock C, Lord K, Taylor B, Tod A. Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2). Trials. 2019 Oct 18;20(1):598. doi: 10.1186/s13063-019-3692-x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2018)
328
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2014)
50
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric Lim e.lim@rbht.nhs.uk
Contact: Study Mailbox Mars2-trial@bristol.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02040272
Other Study ID Numbers  ICMJE MARS2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royal Brompton & Harefield NHS Foundation Trust
Study Sponsor  ICMJE Royal Brompton & Harefield NHS Foundation Trust
Collaborators  ICMJE
  • University of Bristol
  • National Institute for Health Research, United Kingdom
Investigators  ICMJE
Principal Investigator: Eric Lim Royal Brompton & Harefield NHS Foundation Trust
PRS Account Royal Brompton & Harefield NHS Foundation Trust
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP