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| Name | Class |
|---|---|
| University of Bristol | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Experimental | (Extended) pleurectomy decortication |
|
| no surgery | No Intervention | no surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (Extended) pleurectomy decortication | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival to two years | 24 months | |
| Serious adverse health events to two years after randomisation | 24 months | |
| Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Lim | Contact | e.lim@rbht.nhs.uk | ||
| Study Mailbox | Contact | Mars2-trial@bristol.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Eric Lim | Royal Brompton & Harefield NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Health NHS Trust | Recruiting | London | Whitechapel | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38760029 | Derived | Mills N, Farrar N, Warnes B, Ashton KE, Harris R, Rogers CA, Lim E, Elliott D. Strategies to address recruitment to a randomised trial of surgical and non-surgical treatment for cancer: results from a complex recruitment intervention within the Mesothelioma and Radical Surgery 2 (MARS 2) study. BMJ Open. 2024 May 16;14(5):e079108. doi: 10.1136/bmjopen-2023-079108. | |
| 38740044 |
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|
| 24 months |
| 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 |
| Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years |
| 24 Months |
| Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years |
| 24 months |
| The Queen Elizabeth Hospital Birmingham | Recruiting | Birmingham | United Kingdom |
|
| North Bristol Trust | Recruiting | Bristol | United Kingdom |
|
| Papworth | Recruiting | Cambridge | United Kingdom |
|
| Colchester | Recruiting | Colchester | United Kingdom |
|
| Derby | Recruiting | Derby | United Kingdom |
|
| Beatson West of Scotland Cancer Centre | Recruiting | Glasgow | United Kingdom |
|
| Golden Jubilee National Hospital | Not yet recruiting | Glasgow | United Kingdom |
|
| Leeds | Recruiting | Leeds | United Kingdom |
|
| University Hospitals of Leicester NHS Trust | Recruiting | Leicester | United Kingdom |
|
| Barts Health NHS Trust | Recruiting | London | United Kingdom |
|
| Guy's and St Thomas' NHS Foundation Trust | Recruiting | London | United Kingdom |
|
| Royal Marsden | Recruiting | London | United Kingdom |
|
| Maidstone and Tunbridge Wells NHS Trust | Recruiting | Maidstone | United Kingdom |
|
| Wythenshawe | Recruiting | Manchester | United Kingdom |
|
| Clatterbridge | Recruiting | Metropolitan Borough of Wirral | United Kingdom |
|
| South Tees | Recruiting | Middlesbrough | United Kingdom |
|
| South Tyneside NHS Foundation Trust | Recruiting | Newcastle upon Tyne | United Kingdom |
|
| Royal Gwent | Recruiting | Newport | United Kingdom |
|
| Norfolk and Norwich University Hospital | Recruiting | Norwich | United Kingdom |
|
| Oxford University Hospitals | Recruiting | Oxford | United Kingdom |
|
| North West Anglia NHS Foundation Trust | Recruiting | Peterborough | United Kingdom |
|
| University Hospitals Plymouth | Recruiting | Plymouth | United Kingdom |
|
| Sheffield Teaching Hospitals NHS Foundation Trust | Recruiting | Sheffield | United Kingdom |
|
| New Cross | Recruiting | Wolverhampton | United Kingdom |
|
| Lim E, Waller D, Lau K, Steele J, Pope A, Ali C, Bilancia R, Keni M, Popat S, O'Brien M, Tokaca N, Maskell N, Stadon L, Fennell D, Nelson L, Edwards J, Tenconi S, Socci L, Rintoul RC, Wood K, Stone A, Muthukumar D, Ingle C, Taylor P, Cove-Smith L, Califano R, Summers Y, Tasigiannopoulos Z, Bille A, Shah R, Fuller E, Macnair A, Shamash J, Mansy T, Milton R, Koh P, Ionescu AA, Treece S, Roy A, Middleton G, Kirk A, Harris RA, Ashton K, Warnes B, Bridgeman E, Joyce K, Mills N, Elliott D, Farrar N, Stokes E, Hughes V, Nicholson AG, Rogers CA; MARS 2 Investigators. Extended pleurectomy decortication and chemotherapy versus chemotherapy alone for pleural mesothelioma (MARS 2): a phase 3 randomised controlled trial. Lancet Respir Med. 2024 Jun;12(6):457-466. doi: 10.1016/S2213-2600(24)00119-X. Epub 2024 May 10. |
| 32873681 | Derived | 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. |
| 31627746 | Derived | 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. |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
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