Palliative pleurectomy / decortication in patients with malignant pleural mesothelioma after standard chemotherapy. A multicenter, randomised, phase III study. - Palliative pleurectomy in pleural mesothelioma after standard chemotherapy

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 160 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•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

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