Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033280
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2002-04-09
Brief Title:
Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
Status:
COMPLETED
Status Verified Date:
2018-05
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy and radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas
PURPOSE Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas
Detailed Description:
OBJECTIVES
Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy
Determine the toxicity of this regimen in these patients
Determine the survival of patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to response to neoadjuvant temozolomide stable disease or partial response PR vs complete response CR
Patients receive oral temozolomide on days 1-7 and 15-21 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with CR or PR receive 2 courses beyond CR or PR
Within 6 weeks after completion of neoadjuvant temozolomide patients with stable disease or PR undergo radiotherapy 5 days a week for 65 weeks Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy
Patients with CR after completion of neoadjuvant temozolomide undergo observation
Patients are followed at 9 and 12 months every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 37 patients will be accrued for this study within 12 months
Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy
Determine the toxicity of this regimen in these patients
Determine the survival of patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to response to neoadjuvant temozolomide stable disease or partial response PR vs complete response CR
Patients receive oral temozolomide on days 1-7 and 15-21 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with CR or PR receive 2 courses beyond CR or PR
Within 6 weeks after completion of neoadjuvant temozolomide patients with stable disease or PR undergo radiotherapy 5 days a week for 65 weeks Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy
Patients with CR after completion of neoadjuvant temozolomide undergo observation
Patients are followed at 9 and 12 months every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 37 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| CDR0000069270 | None | None | None |