Clinical trial NCT02040272: Mesothelioma and Radical Surgery 2
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mesothelioma
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Bristol
name: National Institute for Health Research, United Kingdom
First posted: 2014-01-20
Enrollment: 328
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Survival
timeFrame: 24 months
Secondary outcomes:
measure: Progression free survival to two years
timeFrame: 24 months
measure: Serious adverse health events to two years after randomisation
timeFrame: 24 months
measure: Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years
timeFrame: 24 months
measure: Resource and health service use to two years and during initial surgical admission for surgical arm
timeFrame: 24 months and during initial surgical admission for surgical arm
measure: Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years
timeFrame: 24 Months
measure: Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
state: Whitechapel
city: Birmingham
country: United Kingdom
facility: The Queen Elizabeth Hospital Birmingham
city: Bristol
country: United Kingdom
facility: North Bristol Trust
city: Cambridge
country: United Kingdom
facility: Papworth
city: Colchester
country: United Kingdom
facility: Colchester
city: Derby
country: United Kingdom
facility: Derby
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Leeds
country: United Kingdom
facility: Leeds
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Marsden
city: Maidstone
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Trust
city: Manchester
country: United Kingdom
facility: Wythenshawe
city: Middlesbrough
country: United Kingdom
facility: South Tees
city: Newcastle upon Tyne
country: United Kingdom
facility: South Tyneside NHS Foundation Trust
city: Newport
country: United Kingdom
facility: Royal Gwent
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
city: Peterborough
country: United Kingdom
facility: North West Anglia NHS Foundation Trust
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Wirral
country: United Kingdom
facility: Clatterbridge
city: Wolverhampton
country: United Kingdom
facility: New Cross
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Eric Lim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim E, Darlison L, Edwards J, Elliott D, Fennell DA, Popat S, Rintoul RC, Waller D, Ali C, Bille A, Fuller L, Ionescu A, Keni M, Kirk A, Koh P, Lau K, Mansy T, Maskell NA, Milton R, Muthukumar D, Pope T, Roy A, Shah R, Shamash J, Tasigiannopoulos Z, Taylor P, Treece S, Ashton K, Harris R, Joyce K, Warnes B, Mills N, Stokes EA, Rogers C; MARS 2 Trialists. 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. BMJ Open. 2020 Sep 1;10(9):e038892. doi: 10.1136/bmjopen-2020-038892.
citation: 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.