Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334594
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2006-06-07
Brief Title:
Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Neoadjuvant Chemotherapy and Extrapleural Pneumonectomy of Malignant Pleural Mesothelioma MPM With or Without Hemithoracic Radiotherapy A Randomized Multicenter Phase II Trial
Status:
COMPLETED
Status Verified Date:
2019-05
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 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 Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Radiation therapy uses high-energy x-rays to kill tumor cells Giving radiation therapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This randomized phase II trial is studying how well giving pemetrexed disodium together with cisplatin followed by surgery with or without radiation therapy works in treating patients with malignant pleural mesothelioma
PURPOSE This randomized phase II trial is studying how well giving pemetrexed disodium together with cisplatin followed by surgery with or without radiation therapy works in treating patients with malignant pleural mesothelioma
Detailed Description:
OBJECTIVES
Primary
Evaluate the short-term outcomes and feasibility of neoadjuvant therapy with pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy in patients with malignant pleural mesothelioma
Evaluate the long-term outcomes and feasibility of postoperative hemithoracic radiotherapy in patients with R0 or R1 resection
Secondary
Determine the quality of life of these patients
Identify predictive and prognostic markers in these patients
Determine relapse-free or progression-free survival and overall survival of these patients
Collect tissue and blood from these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center histology sarcomatous or other vs epithelial or mixed histology nodal status N0-1 vs N2 and extent of disease T1-2 vs T3
Part 1 neoadjuvant therapy and surgery Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Within 8 weeks after completion of neoadjuvant therapy patients without progressive disease undergo extrapleural pneumonectomy
Part 2 Patients achieving R0 or R1 resection proceed to part 2 of study treatment and are randomized to 1 of 2 treatment arms Patients with R2 resection disease progression or symptomatic deterioration after treatment in part 1 are taken off study
Arm I no postoperative radiotherapy Patients do not undergo radiotherapy Quality of life is assessed at baseline and at 6 10 16 and 22 weeks after randomization
Arm II postoperative radiotherapy Beginning within 10 weeks after surgery patients undergo radiotherapy to the hemithoracic region 5 days a week for approximately 5 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and at 4 8 14 and 20 weeks after initiation of radiotherapy
Patients undergo blood and tissue collection at registration and surgery for laboratory and biomarker analysis
After completion of study treatment patients are followed periodically for up to 5 years after surgery
PROJECTED ACCRUAL A total of 155 patients will be accrued for this study
Primary
Evaluate the short-term outcomes and feasibility of neoadjuvant therapy with pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy in patients with malignant pleural mesothelioma
Evaluate the long-term outcomes and feasibility of postoperative hemithoracic radiotherapy in patients with R0 or R1 resection
Secondary
Determine the quality of life of these patients
Identify predictive and prognostic markers in these patients
Determine relapse-free or progression-free survival and overall survival of these patients
Collect tissue and blood from these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center histology sarcomatous or other vs epithelial or mixed histology nodal status N0-1 vs N2 and extent of disease T1-2 vs T3
Part 1 neoadjuvant therapy and surgery Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Within 8 weeks after completion of neoadjuvant therapy patients without progressive disease undergo extrapleural pneumonectomy
Part 2 Patients achieving R0 or R1 resection proceed to part 2 of study treatment and are randomized to 1 of 2 treatment arms Patients with R2 resection disease progression or symptomatic deterioration after treatment in part 1 are taken off study
Arm I no postoperative radiotherapy Patients do not undergo radiotherapy Quality of life is assessed at baseline and at 6 10 16 and 22 weeks after randomization
Arm II postoperative radiotherapy Beginning within 10 weeks after surgery patients undergo radiotherapy to the hemithoracic region 5 days a week for approximately 5 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and at 4 8 14 and 20 weeks after initiation of radiotherapy
Patients undergo blood and tissue collection at registration and surgery for laboratory and biomarker analysis
After completion of study treatment patients are followed periodically for up to 5 years after surgery
PROJECTED ACCRUAL A total of 155 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 |
|---|---|---|---|
| SWS-SAKK-1704 | None | None | None |
| EU-20615 | None | None | None |
| 2006-000445-19 | EUDRACT_NUMBER | None | None |
| LILLY-SAKK-1704 | OTHER | None | None |
| CDR0000481153 | Other Identifier | SAKK | None |