Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung
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|ClinicalTrials.gov Identifier: NCT00030745|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: conventional surgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||May 2003|
|Actual Study Completion Date :||August 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030745
|Zurich, Switzerland, CH-8091|
|Study Chair:||Rolf A. Stahel, MD||UniversitaetsSpital Zuerich|