Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075699
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2004-01-09
Brief Title:
Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2008-06
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 Active symptom control may decrease chest pain breathlessness sweating and general discomfort in patients with malignant pleural mesothelioma It is not yet known if active symptom control is more effective with or without chemotherapy
PURPOSE This randomized phase III trial is studying active symptom control and chemotherapy to see how well they work compared to active symptom control alone in treating patients with malignant pleural mesothelioma
PURPOSE This randomized phase III trial is studying active symptom control and chemotherapy to see how well they work compared to active symptom control alone in treating patients with malignant pleural mesothelioma
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of patients with malignant pleural mesothelioma treated with active symptom control ASC alone vs ASC and mitomycin vinblastine and cisplatin vs ASC and vinorelbine
Secondary
Compare the toxic effects of these regimens in these patients
Compare symptom palliation chest pain breathlessness malaise and sweating attacks in patients treated with these regimens
Compare the performance status of patients treated with these regimens
Compare analgesic usage in patients treated with these regimens
Compare the tumor response and progression-free survival of patients treated with these regimens
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive active symptom control ASC through regular visits at a specialist clinic ASC may include steroids analgesics appetite stimulants bronchodilators andor palliative radiotherapy when required
Arm II Patients receive ASC and chemotherapy comprising mitomycin IV vincristine IV and cisplatin IV on day 1 Chemotherapy repeats every 21 days for a total of 4 courses
Arm III Patients receive ASC and vinorelbine IV over 5 minutes weekly for 6 weeks Vinorelbine repeats every 55 days for a total of 2 courses
Quality of life is assessed at baseline every 3 weeks for 21 weeks and then every 8 weeks thereafter
Patients are followed at 15 18 and 21 weeks and then every 8 weeks thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 840 patients 280 per treatment arm will be accrued for this study within 4 years
Primary
Compare the overall survival of patients with malignant pleural mesothelioma treated with active symptom control ASC alone vs ASC and mitomycin vinblastine and cisplatin vs ASC and vinorelbine
Secondary
Compare the toxic effects of these regimens in these patients
Compare symptom palliation chest pain breathlessness malaise and sweating attacks in patients treated with these regimens
Compare the performance status of patients treated with these regimens
Compare analgesic usage in patients treated with these regimens
Compare the tumor response and progression-free survival of patients treated with these regimens
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive active symptom control ASC through regular visits at a specialist clinic ASC may include steroids analgesics appetite stimulants bronchodilators andor palliative radiotherapy when required
Arm II Patients receive ASC and chemotherapy comprising mitomycin IV vincristine IV and cisplatin IV on day 1 Chemotherapy repeats every 21 days for a total of 4 courses
Arm III Patients receive ASC and vinorelbine IV over 5 minutes weekly for 6 weeks Vinorelbine repeats every 55 days for a total of 2 courses
Quality of life is assessed at baseline every 3 weeks for 21 weeks and then every 8 weeks thereafter
Patients are followed at 15 18 and 21 weeks and then every 8 weeks thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 840 patients 280 per treatment arm will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20349 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000347461 | REGISTRY | None | None |
| ISRCTN54469112 | None | None | None |