Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099125
Status:
COMPLETED
Last Update Posted:
2014-01-24
First Post:
2004-12-08
Brief Title:
Radiation Therapy Temozolomide and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2014-01
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 such as temozolomide and irinotecan work in different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well radiation therapy temozolomide and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme
PURPOSE This phase II trial is studying how well radiation therapy temozolomide and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES
Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with historical controls from the RTOG database
Determine the short- and long-term toxicity of this regimen in these patients
Determine progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter study
Chemoradiotherapy Patients undergo radiotherapy once daily 5 days a week for 6 weeks Concurrently with radiotherapy patients receive oral temozolomide once daily 7 days a week for 6 weeks
Post-radiotherapy chemotherapy Beginning 4-6 weeks after the completion of chemoradiotherapy patients receive irinotecan IV on days 1 and 15 and oral temozolomide once daily on days 1-5 Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 157 patients will be accrued for this study within 11 months
Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with historical controls from the RTOG database
Determine the short- and long-term toxicity of this regimen in these patients
Determine progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter study
Chemoradiotherapy Patients undergo radiotherapy once daily 5 days a week for 6 weeks Concurrently with radiotherapy patients receive oral temozolomide once daily 7 days a week for 6 weeks
Post-radiotherapy chemotherapy Beginning 4-6 weeks after the completion of chemoradiotherapy patients receive irinotecan IV on days 1 and 15 and oral temozolomide once daily on days 1-5 Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 157 patients will be accrued for this study within 11 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 |
|---|---|---|---|
| CDR0000389229 | None | None | None |