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Active Symptom Control With or Without Chemotherapy in Malignant Pleural Mesothelioma
NCT00075699Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2003
- Countries
- 1
- Sponsor
- Medical Research Council
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules, Nucleic Acid-Directed Small Molecules
- Conditions
- malignant pleural mesothelioma (MPM)
01
Overview
Phase 3, randomised, open-label trial of cisplatin, mitomycin c, vincristine and vinorelbine in malignant pleural mesothelioma (MPM) (3 arms), sponsored by Medical Research Council. Primary endpoint: Overall Survival. Started Sep 2003; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Active Symptom Control (ASC)
Regular visits at a specialist clinic. ASC may include steroids, analgesics, appetite stimulants, bronchodilators, and/or palliative radiotherapy.
ASC + MVP Chemotherapy
ASC + mitomycin IV, vincristine IV, and cisplatin IV on day 1. Repeats every 21 days for 4 courses.
ASC + Vinorelbine
ASC + vinorelbine IV weekly for 6 weeks. Repeats every 55 days for 2 courses.
03
Who it enrols
Adults with histologically confirmed malignant pleural mesothelioma diagnosed within the last 3 months, with no prior chemotherapy, adequate organ function, and WHO performance status 0-2.
04
Endpoints
Primary
Overall Survival
Secondary
Palliation of chest pain, breathlessness, malaise, and sweating attacks
Performance status as measured by WHO grade
Analgesic usage
Toxicity as measured by the NCIC CTC
Quality of life as assessed by the EORTC
Tumor response as measured by the RECIST criteria
Progression-free survival as measured by CT scan
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