Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354393
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2006-07-19
Brief Title:
Combination Chemotherapy With or Without Surgery Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2023-05
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 methotrexate vinorelbine 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 Cisplatin may also make tumor cells more sensitive to radiation therapy Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well giving combination chemotherapy with or without surgery and chemoradiotherapy works in treating patients with malignant pleural mesothelioma
PURPOSE This phase II trial is studying how well giving combination chemotherapy with or without surgery and chemoradiotherapy works in treating patients with malignant pleural mesothelioma
Detailed Description:
OBJECTIVES
Primary
Assess the response to induction combination chemotherapy comprising methotrexate vinorelbine ditartrate and cisplatin in patients with previously untreated malignant pleural mesothelioma
Secondary
Assess the tolerability and toxicity of this regimen in these patients
Determine relapse-free and overall survival of patients treated with induction combination chemotherapy with or without surgery and hemithoracic radiation
Assess the impact of induction combination chemotherapy on operability and surgical success
Evaluate the impact of these treatment regimens on quality of life
OUTLINE
Induction chemotherapy Patients receive MVP chemotherapy comprising cisplatin IV over 30-60 minutes on day 1 and vinorelbine ditartrate IV over 5-10 minutes and methotrexate IV over 5-30 minutes on days 8 15 and 22 Treatment repeats every 28 days for 2 courses Patients with unresectable disease may receive up to 2 additional courses of induction chemotherapy Patients requiring palliative radiotherapy or who have progressive disease are removed from the study Patients with resectable disease or sarcomatoid histology and T1-3 N1-2 disease with a complete or partial response to induction chemotherapy proceed to surgery
Surgery Patients with extensive disease undergo palliative debulking pleurectomy and decortication and then are taken off study All other patients undergo a thoracotomy with an extrapleural pneumonectomy and then proceed to chemoradiotherapy
Chemoradiotherapy Beginning 6-10 weeks after surgery patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 6 weeks Patients also receive cisplatin IV over 30-60 minutes on days 1 and 22 Patients with responding disease proceed to adjuvant chemotherapy
Adjuvant chemotherapy Patients receive 2 additional courses of MVP chemotherapy as above
Quality of life is assessed at baseline after each course of induction chemotherapy before surgery and then every 3 months thereafter
After completion of study therapy patients are followed every 3 months
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
Primary
Assess the response to induction combination chemotherapy comprising methotrexate vinorelbine ditartrate and cisplatin in patients with previously untreated malignant pleural mesothelioma
Secondary
Assess the tolerability and toxicity of this regimen in these patients
Determine relapse-free and overall survival of patients treated with induction combination chemotherapy with or without surgery and hemithoracic radiation
Assess the impact of induction combination chemotherapy on operability and surgical success
Evaluate the impact of these treatment regimens on quality of life
OUTLINE
Induction chemotherapy Patients receive MVP chemotherapy comprising cisplatin IV over 30-60 minutes on day 1 and vinorelbine ditartrate IV over 5-10 minutes and methotrexate IV over 5-30 minutes on days 8 15 and 22 Treatment repeats every 28 days for 2 courses Patients with unresectable disease may receive up to 2 additional courses of induction chemotherapy Patients requiring palliative radiotherapy or who have progressive disease are removed from the study Patients with resectable disease or sarcomatoid histology and T1-3 N1-2 disease with a complete or partial response to induction chemotherapy proceed to surgery
Surgery Patients with extensive disease undergo palliative debulking pleurectomy and decortication and then are taken off study All other patients undergo a thoracotomy with an extrapleural pneumonectomy and then proceed to chemoradiotherapy
Chemoradiotherapy Beginning 6-10 weeks after surgery patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 6 weeks Patients also receive cisplatin IV over 30-60 minutes on days 1 and 22 Patients with responding disease proceed to adjuvant chemotherapy
Adjuvant chemotherapy Patients receive 2 additional courses of MVP chemotherapy as above
Quality of life is assessed at baseline after each course of induction chemotherapy before surgery and then every 3 months thereafter
After completion of study therapy patients are followed every 3 months
PROJECTED ACCRUAL A total of 36 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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CCF-IRB-5179 | OTHER | Internal IRB | httpsreporternihgovquickSearchP30CA043703 |