Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482677
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2007-06-04
Brief Title:
Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Canadian Cancer Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase III Study of Temozolomide and Short-Course Radiation Versus Short-Course Radiation Alone In The Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients
Status:
COMPLETED
Status Verified Date:
2020-04
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 Radiation therapy uses high-energy x-rays to kill tumor cells Drugs used in chemotherapy such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving radiation therapy together with temozolomide may kill more tumor cells It is not yet known whether radiation therapy and temozolomide are more effective than radiation therapy alone in treating glioblastoma multiforme
PURPOSE This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme
PURPOSE This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES
Primary
Compare overall survival rates in older patients with newly diagnosed glioblastoma multiforme treated with short-course radiotherapy with or without temozolomide
Secondary
Compare progression-free survival of patients treated with these regimens
Compare the nature severity and frequency of adverse events in patients treated with these regimens
Compare the quality of life of patient treated with these regimens
Determine the methylation status of the O6-methylguanine-DNA methyltransferase promoter
OUTLINE This is a multicenter randomized study Patients are stratified according to center age 65-70 years vs 71-75 years vs 76 years ECOG performance status 0-1 vs 2 and extent of resection at surgery biopsy only vs complete or incomplete resection Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily on days 1-5 8-12 and 15-19 in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily on days 1-25
Beginning 4 weeks after completion of radiotherapy and temozolomide patients receive adjuvant oral temozolomide once daily on days 1-5 Treatment with temozolomide alone repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity
Patients complete quality of life questionnaires at baseline and periodically during study treatment
Tissue samples are collected at baseline and analyzed for methylation status of the O6-methylguanine-DNA methyltransferase promoter
After completion of study treatment patients are followed every 3 months
Primary
Compare overall survival rates in older patients with newly diagnosed glioblastoma multiforme treated with short-course radiotherapy with or without temozolomide
Secondary
Compare progression-free survival of patients treated with these regimens
Compare the nature severity and frequency of adverse events in patients treated with these regimens
Compare the quality of life of patient treated with these regimens
Determine the methylation status of the O6-methylguanine-DNA methyltransferase promoter
OUTLINE This is a multicenter randomized study Patients are stratified according to center age 65-70 years vs 71-75 years vs 76 years ECOG performance status 0-1 vs 2 and extent of resection at surgery biopsy only vs complete or incomplete resection Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily on days 1-5 8-12 and 15-19 in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily on days 1-25
Beginning 4 weeks after completion of radiotherapy and temozolomide patients receive adjuvant oral temozolomide once daily on days 1-5 Treatment with temozolomide alone repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity
Patients complete quality of life questionnaires at baseline and periodically during study treatment
Tissue samples are collected at baseline and analyzed for methylation status of the O6-methylguanine-DNA methyltransferase promoter
After completion of study treatment patients are followed every 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000547163 | OTHER | PDQ | None |
| CAN-NCIC-CE6 | REGISTRY | None | None |
| EORTC-26062-22061 | OTHER | None | None |
| TROG 0802 | OTHER | None | None |
| SPRI-CAN-NCIC-CE6 | None | None | None |