Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052455
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2003-01-24
Brief Title:
Temozolomide Compared to Procarbazine Lomustine and Vincristine in Treating Patients With Recurrent Malignant Glioma
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV
Status:
COMPLETED
Status Verified Date:
2007-05
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known which regimen of chemotherapy is more effective in treating recurrent malignant glioma
PURPOSE Randomized phase III trial to compare the effectiveness of temozolomide alone to that of procarbazine lomustine and vincristine in treating patients who have recurrent malignant glioma
PURPOSE Randomized phase III trial to compare the effectiveness of temozolomide alone to that of procarbazine lomustine and vincristine in treating patients who have recurrent malignant glioma
Detailed Description:
OBJECTIVES
Compare the efficacy of temozolomide vs procarbazine lomustine and vincristine in terms of overall survival in patients with recurrent malignant glioma
Compare progression-free survival of patients treated with these regimens
Compare progression-free survival at 12 weeks in patients treated with two different schedules of temozolomide
Compare the overall survival of patients treated with two different schedules of temozolomide
Compare toxic effects of two different schedules of temozolomide in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized controlled open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm IPatients are randomized to 1 of 2 treatment schedules
Schedule 1 Patients receive oral temozolomide once daily on days 1-5
Schedule 2Patients receive oral temozolomide once daily on days 1-21 Treatment on both schedules repeats every 4 weeks for a maximum of 9 courses in the absence of disease progression or unacceptable toxicity
Arm IIPatients receive oral lomustine and vincristine IV on day 1 and oral procarbazine on days 1-21 Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at 12 and 24 weeks
Patients are followed every 12 weeks
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 500 patients 250 per treatment arm will be accrued for this study
Compare the efficacy of temozolomide vs procarbazine lomustine and vincristine in terms of overall survival in patients with recurrent malignant glioma
Compare progression-free survival of patients treated with these regimens
Compare progression-free survival at 12 weeks in patients treated with two different schedules of temozolomide
Compare the overall survival of patients treated with two different schedules of temozolomide
Compare toxic effects of two different schedules of temozolomide in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized controlled open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm IPatients are randomized to 1 of 2 treatment schedules
Schedule 1 Patients receive oral temozolomide once daily on days 1-5
Schedule 2Patients receive oral temozolomide once daily on days 1-21 Treatment on both schedules repeats every 4 weeks for a maximum of 9 courses in the absence of disease progression or unacceptable toxicity
Arm IIPatients receive oral lomustine and vincristine IV on day 1 and oral procarbazine on days 1-21 Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at 12 and 24 weeks
Patients are followed every 12 weeks
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 500 patients 250 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| ISRCTN83176944 | None | None | None |
| MRC-BR12 | None | None | None |
| EU-20114 | None | None | None |