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 (NCT)	NCT00075699
Protocol serial number	E164/44
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

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

Respiratory Unit
Leeds General Infirmaty
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 243 2799
Email	none@provided.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Phase II
Drug / device / biological / vaccine name(s)	Mitomycin, vinblastine, cisplatin, vinorelbine
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/08/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Respiratory Unit

Leeds
LS1 3EX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Study website	Study website	11/11/2025	11/11/2025	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.