Medical Research Council (MRC)/British Thoracic Society (BTS) phase II feasibility trial of the management of mesothelioma
| ISRCTN | ISRCTN54469112 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54469112 |
| ClinicalTrials.gov number | NCT00075699 |
| Secondary identifying numbers | E164/44 |
- Submission date
- 21/09/2000
- Registration date
- 21/09/2000
- Last edited
- 29/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Martin F Muers
Scientific
Scientific
Respiratory Unit
Leeds General Infirmaty
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 243 2799 |
|---|---|
| none@provided.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Medical Research Council (MRC)/British Thoracic Society (BTS) phase II feasibility trial of the management of mesothelioma |
| Study acronym | MESO-1 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2000 |
| Completion date | 31/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 120 |
| Total final enrolment | 409 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 31/08/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Respiratory Unit
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Feasibility study results: | 01/02/2004 | Yes | No | |
| Results article | Main trial results: | 17/05/2008 | Yes | No | |
| Plain English results | 28/09/2009 | 29/10/2021 | No | Yes |
Editorial Notes
29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
