Mesothelioma And Radical Surgery
| ISRCTN | ISRCTN95583524 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95583524 |
| ClinicalTrials.gov number | NCT00253409 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/05/2004
- Registration date
- 05/07/2004
- Last edited
- 18/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
This study was designed to investigate the effectiveness of a form of major surgery known as extra pleural pneumonectomy (EPP) for patients diagnosed with malignant pleural mesothelioma (a malignant tumour involving the lining of the lung). The benefits considered were longer survival and/or improved quality of life.
Mesothelioma surgery is usually accompanied by chemotherapy and, where appropriate, it is followed by radiotherapy. Because the available knowledge on patientsÂ’ outcome was from those who had received all three forms of cancer treatment as a package (chemotherapy, surgery and radiotherapy), it was not possible to determine from the existing evidence whether the surgical component itself was helpful to them.
Who can participate?
Patients 18 years of age or older with pleural mesothelioma, considered suitable for these treatments based on the knowledge available in the early 2000s when the study was being planned, were asked to give written consent to join the study.
What does the study involve?
Participants were given chemotherapy and then had further tests. Their response to chemotherapy and the results of the tests were reviewed by a team of medical specialists. Patients assessed as suitable (in terms of their general health and the extent of the cancer) were invited to consent to be randomly allocated to have EPP surgery, followed by radiotherapy, or to not have EPP surgery.
What are the possible benefits and risks of participating?
Not provided.
Where is the study run from?
The study was conducted in 12 hospitals located throughout the UK. The Clinical Trials and Statistics Unit at The Institute of Cancer Research co-ordinated the study.
When is the study starting and how long is it expected to run for?
The study ran from July 2006 to July 2009.
Who is funding the study?
Cancer Research UK and the June Hancock Mesothelioma Fund.
Who is the main contact?
Professor Tom Treasure
mars-icrctsu@icr.ac.uk
Contact information
Scientific
Clinical Operation Research Unit
Dept of Mathematics
University College
Taviton Street
London
WC1H 0BT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | Mesothelioma And Radical Surgery |
| Study acronym | MARS |
| Study hypothesis | Added 06/08/09: 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. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Mesothelioma |
| Intervention | Prior to randomisation all patients undergo 3 cycles of cisplatin based chemotherapy. Randomisation arms are with or without extrapleural pneumonectomy (EPP) surgical intervention. Those with EPP will go on to have radical radiotherapy. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 05/07/2006 |
| Overall study end date | 05/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 100 (50 in each arm) (Added 06/09/2011: 50 patients in total randomised to the Feasibility Study) |
| Participant inclusion criteria | Two phase eligibility: Registration Eligibility criteria at registration: 1. 18 years of age or older 2. Histologically proven mesothelioma 3. Fit to undergo extrapleural pneumonectomy (EPP) as per British Thoracic Society (BTS) guidelines 4. Fit to undergo the planned post-operative radiotherapy 5. Able to complete Quality of Life questionnaires 6. Able to comply with follow-up requirements 7. Written informed consent for registration 8. Positron emission tomography (PET) or mediastinoscopy negative 9. No distant metastases Once chemotherapy has been completed a further eligibility criteria is checked to determine continued eligibility for randomisation. Eligibility criteria for randomisation: 1. Still fulfil eligibility criteria for registration 2. Completion of 3 cycles of chemotherapy 3. Operable disease (T1-3, N0-1, M0) 4. Biopsy proven malignant mesothelioma on histology and immuno-histochemistry 5. Normal renal function 6. World Health Organisation (WHO) performance status 0 or 1 7. Written informed consent for randomisation |
| Participant exclusion criteria | 1. Predicted post-operative forced expiratory volume in 1 second (FEV1) of less than 40% and carbon monoxide transfer factor (TLCO) of less than 40% 2. Significant pulmonary hypertension 3. Cardiac ejection fraction of less than 40% |
| Recruitment start date | 05/07/2006 |
| Recruitment end date | 05/07/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
WC1H 0BT
United Kingdom
Sponsor information
Hospital/treatment centre
Prof Tom Treasure
Clinical Operation Research Unit
Dept of Mathematics
University College
Taviton Street
London
WC1H 0BT
England
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Protocol article | protocol | 01/02/2006 | Yes | No | |
| Results article | results | 01/10/2009 | Yes | No | |
| Results article | results | 01/08/2011 | Yes | No |
Editorial Notes
18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
