Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227630
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2005-09-26
Brief Title:
Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2012-07
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 such as pemetrexed disodium and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Radiation therapy uses high-energy x-rays to kill tumor cells Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed Giving radiation therapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well giving pemetrexed disodium and cisplatin followed by surgery and radiation therapy works in treating patients with malignant pleural mesothelioma
PURPOSE This phase II trial is studying how well giving pemetrexed disodium and cisplatin followed by surgery and radiation therapy works in treating patients with malignant pleural mesothelioma
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of neoadjuvant chemotherapy comprising pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy and high-dose postoperative 3D-conformal radiotherapy in terms of 90-day progression-free survival in patients with malignant pleural mesothelioma
Secondary
Determine the toxicity of this regimen in these patients
Determine progression-free survival and overall survival of patients treated with this regimen
OUTLINE This is a non-randomized multicenter study
Neoadjuvant chemotherapy Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity Patients are evaluated 3 weeks after completion of neoadjuvant chemotherapy Patients without disease progression proceed to surgery
Extrapleural pneumonectomy Within 21-56 days after completion of neoadjuvant chemotherapy patients undergo extrapleural pneumonectomy Patients are evaluated 30 days after surgery Patients without disease progression undergo high-dose 3D-conformal radiotherapy
High-dose 3D-conformal radiotherapy Beginning 30-84 days after surgery patients undergo high-dose 3D-conformal radiotherapy daily for 30 days
After completion of study treatment patients are followed on days 42 and 90 every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study
Primary
Determine the feasibility of neoadjuvant chemotherapy comprising pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy and high-dose postoperative 3D-conformal radiotherapy in terms of 90-day progression-free survival in patients with malignant pleural mesothelioma
Secondary
Determine the toxicity of this regimen in these patients
Determine progression-free survival and overall survival of patients treated with this regimen
OUTLINE This is a non-randomized multicenter study
Neoadjuvant chemotherapy Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity Patients are evaluated 3 weeks after completion of neoadjuvant chemotherapy Patients without disease progression proceed to surgery
Extrapleural pneumonectomy Within 21-56 days after completion of neoadjuvant chemotherapy patients undergo extrapleural pneumonectomy Patients are evaluated 30 days after surgery Patients without disease progression undergo high-dose 3D-conformal radiotherapy
High-dose 3D-conformal radiotherapy Beginning 30-84 days after surgery patients undergo high-dose 3D-conformal radiotherapy daily for 30 days
After completion of study treatment patients are followed on days 42 and 90 every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 52 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 |
|---|---|---|---|
| EORTC-08031 | None | None | None |
| 2004-004273-28 | EUDRACT_NUMBER | None | None |