Condition category
Cancer
Date applied
21/09/2000
Date assigned
21/09/2000
Last edited
21/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctu.mrc.ac.uk/studies/MESO_1.asp

Contact information

Type

Scientific

Primary contact

Dr Martin F Muers

ORCID ID

Contact details

Respiratory Unit
Leeds General Infirmaty
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 243 2799

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 Committee’s (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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes