Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006353
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-10-04
Brief Title:
Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Status:
COMPLETED
Status Verified Date:
2012-09
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 damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES I Compare the efficacy of radiotherapy with or without temozolomide in terms of overall survival in patients with newly diagnosed glioblastoma multiforme II Compare the toxicity profiles of these regimens in these patients III Compare the progression free survival of these patients treated with these regimens IV Compare the quality of life in these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center age under 50 vs 50 and over WHOECOG performance status 0-1 vs 2 and extent of surgical resection biopsy only vs complete or incomplete resection Patients are randomized to one of two treatment arms Arm I Patients undergo radiotherapy 5 days a week for 6 weeks Arm II Patients undergo radiotherapy as in arm I concurrently with oral temozolomide daily for 6 weeks Patients then receive adjuvant oral temozolomide alone on days 1-5 every 28 days for 6 courses beginning 4 weeks after completion of radiotherapy Quality of life is assessed prior to the study at week 4 during radiotherapy at 4 weeks after completion of radiotherapy at the end of courses 3 and 6 of adjuvant chemotherapy arm II and then every 3 months until disease progression Patients are followed every 3 months until disease progression or death
PROJECTED ACCRUAL A total of 520 patients 260 per treatment arm will be accrued for this study within 35 years
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center age under 50 vs 50 and over WHOECOG performance status 0-1 vs 2 and extent of surgical resection biopsy only vs complete or incomplete resection Patients are randomized to one of two treatment arms Arm I Patients undergo radiotherapy 5 days a week for 6 weeks Arm II Patients undergo radiotherapy as in arm I concurrently with oral temozolomide daily for 6 weeks Patients then receive adjuvant oral temozolomide alone on days 1-5 every 28 days for 6 courses beginning 4 weeks after completion of radiotherapy Quality of life is assessed prior to the study at week 4 during radiotherapy at 4 weeks after completion of radiotherapy at the end of courses 3 and 6 of adjuvant chemotherapy arm II and then every 3 months until disease progression Patients are followed every 3 months until disease progression or death
PROJECTED ACCRUAL A total of 520 patients 260 per treatment arm will be accrued for this study within 35 years
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 |
|---|---|---|---|
| EORTC-22981 | None | None | None |
| EORTC-26981 | None | None | None |
| CAN-NCIC-CE3 | None | None | None |