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ISRCTN
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ISRCTN54469112
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DOI
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10.1186/ISRCTN54469112
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ClinicalTrials.gov identifier
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NCT00075699
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EudraCT number
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Public title
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Medical Research Council (MRC)/British Thoracic Society (BTS) phase II feasibility trial of the management of mesothelioma
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Scientific title
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Acronym
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MESO-1
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Serial number at source
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E164/44
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Study hypothesis
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The incidence of mesothelioma is rising rapidly in the UK. There is no generally accepted standard treatment. The British Thoracic Society (BTS) recommends active symptom control (ASC). It is not known whether chemotherapy in addition prolongs survival or provides worthwhile palliation with acceptable toxicity.
The aim of the present study was to assess the acceptability of the trial design to patients and the suitability of two standard quality of life (QL) questionnaires for mesothelioma.
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Lay summary
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Ethics approval
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Multicentre Research Ethics Committees (MREC) approval of the protocol was obtained. Confirmation of Local Research Ethics Committee’s (LREC) approval was required before a centre could start registering patients
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mesothelioma
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Participants - inclusion criteria
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1. Microscopically and immunohistochemically confirmed malignant mesothelioma including epithelial and other histological types
2. Any symptomatic pleural effusion treated and brought under control before trial entry
3. Computed tomography (CT) scan to be performed within a month prior to randomisation
4. Patients who have undergone surgical resection of mesothelioma are eligible provided two CT scans, six weeks apart show stable or progressive disease
5. No previous chemotherapy for mesothelioma
6. No other disease or previous malignancy
7. World Health Organization (WHO) performance status zero to two
8. Medically fit to receive chemotherapy
9. Quality of life (QOL) forms completed
10. Signed informed consent
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/09/2000
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Anticipated end date
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31/08/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120
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Interventions
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Three Arms:
1. Active symptom control (ASC) only
2. ASC and mitomycin (8 mg/m^2), vinblastine (6 mg/m^2) and cisplatin (50 mg/m^2) every 21 days for four cycles
3. ASC and vinorelbine six weekly injections (30 mg/m^2) followed by a two week interval and a further course of six weekly injections
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Primary outcome measure(s)
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The outcome measures were:
1. The acceptability of the study design to patients
2. Suitability of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and EORTC Lung Cancer 13-item module (LC13) and Functional Assessment of Cancer Therapy - Lung (FACT-L) QOL questionnaires for mesothelioma
3. Palliation
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Medical Research Council (UK)
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Trial website
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http://www.ctu.mrc.ac.uk/studies/MESO_1.asp
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Publications
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Results:
1. Feasibility study results: http://www.ncbi.nlm.nih.gov/pubmed/14760156
2. Main trial results: http://www.ncbi.nlm.nih.gov/pubmed/18486741
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Contact name
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Dr
Martin F
Muers
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Address
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Respiratory Unit
Leeds General Infirmaty
Great George Street
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City/town
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Leeds
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Zip/Postcode
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LS1 3EX
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Country
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United Kingdom
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Tel
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+44 (0)113 243 2799
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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21/09/2000
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Last edited
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21/05/2008
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Date ISRCTN assigned
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21/09/2000
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