Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00075699
Protocol/serial number
E164/44
Study information
Scientific title
Acronym
MESO-1
Study hypothesis
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.
Ethics approval
Multicentre Research Ethics Committees (MREC) approval of the protocol was obtained. Confirmation of Local Research Ethics Committees (LREC) approval was required before a centre could start registering patients
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Mesothelioma
Intervention
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
Intervention type
Drug
Phase
Phase II
Drug names
Mitomycin, vinblastine, cisplatin, vinorelbine
Primary outcome measure
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
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2000
Overall trial end date
31/08/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
120
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/09/2000
Recruitment end date
31/08/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Respiratory Unit
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Feasibility study results
Muers MF, Rudd RM, O'Brien ME, Qian W, Hodson A, Parmar MK, Girling DJ, , BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112., Thorax, 2004, 59, 2, 144-148.
-
Main trial results
Muers MF, Stephens RJ, Fisher P, Darlison L, Higgs CM, Lowry E, Nicholson AG, O'Brien M, Peake M, Rudd R, Snee M, Steele J, Girling DJ, Nankivell M, Pugh C, Parmar MK, , Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomised trial., Lancet, 2008, 371, 9625, 1685-1694, doi: 10.1016/S0140-6736(08)60727-8.