Malignant Mesothelioma Clinical Trial
Official title:
Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor
so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients who have mesothelioma of the lung.
OBJECTIVES:
- 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
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