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Medical Research Council (MRC)/British Thoracic Society (BTS) phase II feasibility trial of the management of mesothelioma

Medical Research Council (MRC)/British Thoracic Society (BTS) phase II feasibility trial of the management of mesothelioma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN54469112
Enrollment
120
Registered
2000-09-21
Start date
2000-09-01
Completion date
Unknown
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesothelioma Cancer Malignant neoplasms

Interventions

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

Sponsors

Medical Research Council (MRC) (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026