mesothelioom
Conditions
Interventions
Pleurectomy-decortication will be performed preferably as a minimal invasive
procudure (Video-assisted thoracoscopy). If this is impossible an open
thoracotomy will be performed. Primary objective i
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Fit enough to undergo pleurectomy / decortication after 4-6 courses cisplatinum- pemetrexed.;Histological proven malignant pleural mesothelioma;Any T, except extension to contralateral pleura, abdomen, or invasion of the myocardium, any N any M.;Performance status WHO 0 or 1;Weight loss
Exclusion criteria
Exclusion criteria: Objective progressive disease after 4-6 cycles of standard chemotherapy with cisplatin and pemetrexed.;Ongoing grade >=2 toxicity (CTC v 3.0) due to prior standard chemotherapy other than alopecia, polyneuropathy and tinnitus.;Weight loss > 10% in last 3 months before randomisation;Prior chest radiotherapy (except radiotherapy on chest tube port).;Prior or current other malignancies, except if longer than 5 years ago and adequately treated.;No other severe medical illness, including psychosis. ;Any concurrent anti-cancer treatment or use of investigational drugs. Palliative radiotherapy is allowed.;Uncontrolled infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain score (VAS) Dyspnea (VAS) Quality of Life Time to disease progession Improvement in lung function | — |
Countries
Netherlands
Outcome results
None listed