Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura
- Determine the proportion of patients with potentially resectable mesothelioma of the
pleura remaining operable after treatment with neoadjuvant cisplatin and gemcitabine.
- Determine the response rate and overall survival of patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
- Determine the number of postoperative hospitalization days and occurrence and duration
of surgical complications in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Compare the proportion of patients who report psychological distress at 3 months after
surgery vs at study registration.
OUTLINE: Patients receive cisplatin IV on day 1 and gemcitabine IV on days 1, 8, and 15.
Treatment repeats every 28 days for 3 courses. Within 6 weeks after completion of
chemotherapy, patients undergo restaging by CT scan followed by surgical resection.
Quality of life is assessed at baseline, day 1 of course 3, within 4 weeks after surgery,
and then at 3 and 6 months.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rolf A. Stahel, MD