MARS 2: A Feasibility Study Comparing (Extended) Pleurectomy Decortication ... | Recruiting
MARS 2: A Feasibility Study Compari... | Recruiting
MARS 2: A Feasibility Study Comparing (Extended) Pleurectomy Decortication Versus no Pleurectomy Decortication in Patients With Malignant Pleural Mesothelioma
MARS2

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Medical Conditions
  • Mesothelioma
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02040272
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2300 people in the UK are diagnosed with mesothelioma each year and the average survival is approximately 17 months. Exposure to asbestos is the most common cause although the cancer does not usually become apparent until 30-40 years after exposure. Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) surgery 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 determine if it is feasible to enrol patients with mesothelioma into a study randomising them to chemotherapy only or chemotherapy and lung-sparing surgery. Patients will be followed up regularly at their usual clinic visits for to 5 years. Patients will be asked to complete a Quality of Life Questionnaire at these visits. Tissue samples will be taken at the time of diagnosis and at surgery (if they are randomised to surgery) for mesothelioma research central storage and blood samples will be taken at the clinic visits up to 12 months for mesothelioma research central storage. If we can show the feasibility of recruitment we will apply to continue the study to include more patients in order to determine if lung-sparing surgery improves survival and quality of life for mesothelioma patients.
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Procedure : (Extended) pleurectomy decortication

Study Arm Groups : Surgery

Intervention Type
See Interventions above
Primary Outcome Measures
    Ability to randomise 50 patients; 24 months
Secondary Outcome Measures
    Survival from the time point of randomisation; Follow up for up to 5 years; Quality of life as assessed using QLQ 30 and LC-13 scales; Follow up for up to 5 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
N/A - N/A
Who Can Participate
Patients
Number of Participants
50
Participant Inclusion Criteria
    Inclusion Criteria:

    - 1. Histological confirmation of mesothelioma, 2. Disease confined to one hemi-thorax.

    Exclusion Criteria:

    - 1. Unable to give informed consent, 2. Patients unwilling to be randomised, 3. Extent of disease not deemed to be surgically resectable, 4. ECOG status 2 or more, 5. Patients with predicted pre-operative FEV1 or TLco less than 20%, 6. Patients with severe heart failure (EF less than 30%), 7. Patients with end stage kidney failure requiring dialysis, 8. Patients with liver failure, 9. Patients who are participating in another interventional clinical trial.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Cambridge
Cambridgeshire
Local Institution
London
Greater London
Manchester
Cardiff
Newcastle upon Tyne
Sheffield
Leeds
Uni Hospital Leicester
Leicester
Derby
Research Site
Wirral
Colchester General Hospital
Colchester
The James Cook University Hospital
Middlesbrough
Local Institution
Newport
Gwent
Research Site
Wolverhampton
Burton Hospitals NHS Foundation Trust
Burton upon Trent
Trial Contact(s)
Primary Trial Contact
Other Trial Contacts
Jane Elliott
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Study to Determine if it is Feasible to Recruit Into a Randomised Trial Comparing (Extended) Pleurectomy Decortication Versus no Pleurectomy Decortication in Patients With Malignant Pleural Mesothelioma
EudraCT Number
Not available for this trial
Funder(s)
  • Cancer Research UK
  • Papworth Hospital NHS Foundation Trust
Other Study ID Numbers
MARS2
Sponsor(s)
Royal Brompton & Harefield NHS Foundation Trust
Key Dates

Recruitment Start Date

May 2015

Recruitment End Date

May 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

20 Dec 2013

Date updated in source

11 May 2017