Medical Research Council (MRC)/British Thoracic Society (BTS) phase II feasibility trial of the management of mesothelioma
- Conditions
- MesotheliomaCancerMalignant neoplasms
- Registration Number
- ISRCTN54469112
- Lead Sponsor
- Medical Research Council (MRC) (UK)
- Brief Summary
2004 Results article in http://www.ncbi.nlm.nih.gov/pubmed/14760156 Feasibility study results: 2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18486741 Main trial results:
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 409
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
Not provided at time of registration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> The outcome measures were:<br> 1. The acceptability of the study design to patients<br> 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<br> 3. Palliation<br>
- Secondary Outcome Measures
Name Time Method o secondary outcome measures