Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin and Intravenous Sodium Thiosulfate in the Multimodality Treatment of Malignant Pleural Mesothelioma
- Patients will undergo surgery with pleurectomy/decortication which entails the removal
of the inner and outer skin of the lung, including the pleura overlying the pericardium
and diaphragm. Resection of the pericardium and diaphragm are occasionally necessary
to debulk the tumor. This surgery is part of standard care for pleural mesothelioma.
- After surgery, a one hour lavage with heated cisplatin will be administered to the
hemithorax (and abdominal regions if the diaphragm is no longer present). The lung
itself is not removed, only the diseased portion of the lung and surrounding areas with
- Immediately following the one-hour lavage, a six hour infusion of sodium thiosulfate
will begin to help reduce the side effects of the cisplatin.
- Patients will remain hospitalized until they have recovered from surgery (usually 7-14
- Patients will return to the hospital three months after their surgery to have fluid
drawn from their chest via an ultrasound guided thoracentesis. This is called a saline
- Patients will be in the study actively for three months. This includes a 2-week and
4-week post-operative follow-up in which blood work is performed. As well as a 3-month
follow-up for the saline wash. Long-term follow-up includes computed tomography of the
chest and abdomen every 6 months to assess recurrence.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma,
David J. Sugarbaker, MD
Brigham and Women's Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|