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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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MARS
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Mesothelioma and Radical Surgery trial. MARS pilot study - to determine the feasibility and acceptability of performing a randomised trial comparing extra-pleural pneumonectomy (EPP) against no EPP surgery within the context of trimodality therapy (chemot
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Topic
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Cancer
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Portfolio Eligibility
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Funded by UKCRC partner
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ISRCTN
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95583524
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EudraCT
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MREC N° |
04/05/008
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UKCRN ID |
1189
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WHO ID
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Research Summary
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To determine whether 50 malignant mesothelioma patients can be randomised to radical surgery versus best palliative care within a year. It will also determine the effects of surgery on survival and quality of life and provided that recruitment & safety data are acceptable, it will be extended to an international randomised trial with the aim of providing definitive data on the value of Extra-Pleural Pneumonectomy (EPP) surgery in the treatment of early stage malignant mesothelioma.
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Study Type |
not specified
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Design Type |
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Disease(s) |
Mesothelioma
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Phase |
III
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Current Status
| Closed - in follow-up |
| Closure Date | 12/02/2010 |
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Sample Size
| 50 |
| Accrual to Date |
 | 96% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| Unknown (also active in England) |
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Main Inclusion Criteria
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Eligibility criteria at registration:
· 18 years of age or older
· Histologically proven mesothelioma
· Fit to undergo EPP as per BTS guidelines
· Fit to undergo the planned post-operative radiotherapy
· Able to complete Quality of Life questionnaires
· Able to comply with follow-up requirements
· Written informed consent for registration
· No distant metastases
Eligibility criteria for randomisation
· Still fulfil eligibility criteria for registration
· Completion of 3 cycles of chemotherapy
· Operable disease (T1-3, N0-1, M0)
· Biopsy proven malignant mesothelioma on histology and immuno-histochemistry
· Normal renal function
· WHO performance status 0 or 1
· Written informed consent for randomisation
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Main Exclusion Criteria
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· Predicted post-operative FEV1 of less than 40% and TLCO of less than 40%.
· Significant pulmonary hypertension
· Cardiac ejection fraction of less than 40%
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Chief Investigator(s)
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| Prof Julian Peto | Prof Tom Treasure |
| Mr David Waller |
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Further details, please contact
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Mr David Waller
University Hospitals of Leicester NHS Trust
Leicester Royal Infirmary
Infirmary Square
Leicester
Leicestershire
LE1 5WW
UNITED KINGDOM
debra.grew@uhl-tr.nhs.uk
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Funder(s) |
June Hancock Mesothelioma Research Fund
Cancer Research UK
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Sponsor(s) |
Guy's and St. Thomas' NHS Foundation trust
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