Palliative pleurectomy / decortication in patients with malignant pleural mesothelioma after standard chemotherapy. A multicenter, randomised, phase III study.
- Conditions
- mesothelioom100274121003559710006295
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
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 < 10% in last 3 months;Standard chemotherapy with pemetrexed and cisplatin which must have resulted in CR, PR or SD;No prior chest radiotherapy ;No prior or other malignancies, except if longer than 5 yrs ago and adequately treated;No uncontrolled infection
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Overall survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pain score (VAS)<br /><br>Dyspnea (VAS)<br /><br>Quality of Life<br /><br>Time to disease progession<br /><br>Improvement in lung function</p><br>