Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030459
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2002-02-14
Brief Title:
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
Sponsor:
British Thoracic Society
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma
Status:
UNKNOWN
Status Verified Date:
2003-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Palliative therapy may help patients with advanced cancer live more comfortably It is not yet known if palliative therapy is more effective with or without chemotherapy in treating patients who have malignant mesothelioma
PURPOSE Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have malignant mesothelioma
PURPOSE Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have malignant mesothelioma
Detailed Description:
OBJECTIVES
Determine the feasibility of palliative therapy alone versus palliative therapy with mitomycin vinblastine and cisplatin versus palliative therapy with vinorelbine in patients with malignant mesothelioma
Determine the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of three treatment arms
Arm I Patients receive palliative therapy alone comprising non-chemotherapeutic therapy eg radiotherapy painkillers steroids relaxants and special pain relief techniques
Arm II Patients receive palliative therapy as in arm I and chemotherapy comprising mitomycin IV courses 1 2 and 4 only vinblastine IV and cisplatin IV over 4 hours on day 1 Chemotherapy repeats every 21 days for a total of 4 courses
Arm III Patients receive palliative therapy as in arm I and chemotherapy comprising vinorelbine IV over 5 minutes once weekly on weeks 1-6 and 9-14
Quality of life is assessed at baseline for all patients at weeks 3 6 9 and 12 for arm I at weeks 4 7 10 and 13 for arm II at weeks 3 6 10 and 13 for arm III at weeks 21 and 29 and then every 8 weeks thereafter for all patients
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 60 patients 20 per treatment arm will be accrued for this study within 1 year
Determine the feasibility of palliative therapy alone versus palliative therapy with mitomycin vinblastine and cisplatin versus palliative therapy with vinorelbine in patients with malignant mesothelioma
Determine the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of three treatment arms
Arm I Patients receive palliative therapy alone comprising non-chemotherapeutic therapy eg radiotherapy painkillers steroids relaxants and special pain relief techniques
Arm II Patients receive palliative therapy as in arm I and chemotherapy comprising mitomycin IV courses 1 2 and 4 only vinblastine IV and cisplatin IV over 4 hours on day 1 Chemotherapy repeats every 21 days for a total of 4 courses
Arm III Patients receive palliative therapy as in arm I and chemotherapy comprising vinorelbine IV over 5 minutes once weekly on weeks 1-6 and 9-14
Quality of life is assessed at baseline for all patients at weeks 3 6 9 and 12 for arm I at weeks 4 7 10 and 13 for arm II at weeks 3 6 10 and 13 for arm III at weeks 21 and 29 and then every 8 weeks thereafter for all patients
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 60 patients 20 per treatment arm will be accrued for this study within 1 year
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-20134 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069167 | REGISTRY | None | None |
| MRC-BTS-MESO-1 | None | None | None |