Mesothelioma and Radical Surgery 2

Mesothelioma Clinical Trial

— MARS2  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02040272
• Other study ID #: MARS2
• Status: Recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: September 2022

Study information

• Verified date: October 2019
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: Eric Lim
• Email: e.lim[@]rbht.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 328
• Est. completion date: September 2022
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma

Intervention

Procedure:
• (Extended) pleurectomy decortication

Locations

Country	Name	City	State
United Kingdom	The Queen Elizabeth Hospital Birmingham	Birmingham
United Kingdom	North Bristol Trust	Bristol
United Kingdom	Papworth	Cambridge
United Kingdom	Colchester	Colchester
United Kingdom	Derby	Derby
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	Leeds	Leeds
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Barts Health NHS Trust	London	Whitechapel
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Royal Marsden	London
United Kingdom	Maidstone and Tunbridge Wells NHS Trust	Maidstone
United Kingdom	Wythenshawe	Manchester
United Kingdom	South Tees	Middlesbrough
United Kingdom	South Tyneside NHS Foundation Trust	Newcastle upon Tyne
United Kingdom	Royal Gwent	Newport
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United Kingdom	Oxford University Hospitals	Oxford
United Kingdom	North West Anglia NHS Foundation Trust	Peterborough
United Kingdom	University Hospitals Plymouth	Plymouth
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	Clatterbridge	Wirral
United Kingdom	New Cross	Wolverhampton

Sponsors (3)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	National Institute for Health Research, United Kingdom, University of Bristol

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	The time from randomisation to death will be measured and date of death will be collected on purposely designed case report forms.	24 months
Secondary	Progression free survival to two years		24 months
Secondary	Serious adverse health events to two years after randomisation		24 months
Secondary	Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years	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.	24 months
Secondary	Resource and health service use to two years and during initial surgical admission for surgical arm		24 months and during initial surgical admission for surgical arm
Secondary	Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years	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	24 Months
Secondary	Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years	VAS (visual analogue scale) score. Ranges from 0 to 100.; A higher score indicates better quality of life	24 months