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

Pleural mesothelioma is a malignant disease of the pleura. The disease usually
spreads loco-regionally with in rare cases distant metastases late in the
course of the disease. As a result, patients suffer often from heavy pain and
dyspnea due to thoracic wall ingrowth, shrinking of the affected hemithorax and
/ or pleural fluid. Consequently, patients usually die as a result of
loco-regional complications and not as a result of distant metastatic disease.

The question is whether a debulking procedure with removal of the majority of
the tumor mass and the affected pleura by palliative pleurectomy /
decortication after standard chemotherapy consisting of cisplatin and
pemetrexed might lead to an improvement in overall survival and a decrease in
pain, dyspnea and an improvement in quality of life as a result of a better
expansion of the affected lung and less ingrowth in the thoracic wall and other
surrounding structures.

This hypothesis is supported by evidence from non-randomised retrospective
studies suggesting that palliative pleurectomy / decortication may indeed lead
to an improvement (doubling) of the overall survival

Primary objective is to investigate whether palliative pleurectomy /
decortication after 4-6 courses of standard chemotherapy with cisplatin and
pemetrexed will lead to a doubling of the overall survival compared to a
control group which will receive best supportice care


Secondary obejectives are to investigate whether palliative pleuractomy will
lead to improvement in quality of life with less pain and dyspnea compared to
the control arm which will receive best supportive care

This a prospective randomised controlled trial (phase III study) comparing
palliative pleurectomy-decortication with best supportive care without disease
progression after 4-6 courses cisplatin-pemetrexed

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 is to remove as much as
possible tumor mass (debulking procedure) without removing the lung. The extent
of resection will be scored for predefined regions of the thoracic cavity and
the removed tumor mass will be weighted according to palliative surgery for
ovarium cancer. Prostetic reconstruction of the pericardium or diaphragm is
allowed if needed. The operation should take place within 11 weeks after the
first day of the last chemotherapy course.

Possible complication of a video-assisted or open thoracotomy for
pleuractomy-decortication are

- post-operative pain
- pneumonia
-persistent air leak and chest tube
-empyema
-cardiac arrythmias

Is is expected that patients will stay on average for 5 days in the hospital

Based on previous studies with pleurectomy-decortication in mesothelioma
patients, the operative mortality is less than 5 %, comparable with other
operative pulmonary procedures.