Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030745
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2002-02-14
Brief Title:
Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have mesothelioma of the lung
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20136 | Other Identifier | SAKK | None |
| SWS-SAKK-17-00 | OTHER | None | None |