Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114140
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2005-06-13
Brief Title:
Temozolomide and Radiation Therapy in Treating Patients With Gliomas
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2022-05
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 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 Radiation therapy uses high-energy x-rays to kill tumor cells Giving temozolomide together with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with low-grade gliomas
PURPOSE This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with low-grade gliomas
Detailed Description:
OBJECTIVES
Compare the 3-year survival of patients with high-risk low-grade gliomas treated with temozolomide and radiotherapy followed by temozolomide alone with that of patients enrolled on European Organization for Research and Treatment of Cancer EORTCclinical trials EORTC-22844 and EORTC-22845
Determine the toxicity of this regimen in these patients
Determine the association between progression-free survival and O6-methylguanine-DNA methyltransferase MGMT methylation status in patients treated with this regimen
Determine the association between survival and MGMT methylation status in patients treated with this regimen
Determine the quality of life QOL of patients treated with this regimen
Determine the neurocognitive function of patients treated with this regimen
Evaluate the feasibility of collecting patient-reported QOL and neurocognitive assessments over 3 years
OUTLINE This is a non-randomized multicenter study
Patients receive oral temozolomide once daily on days 1-42 and undergo radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 and 36-40 one hour before RT weekdays in the evening weekends Beginning 28 days after completion of chemoradiotherapy patients receive oral temozolomide once daily on days 1-5 Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 6 months 12 months
After completion of study treatment patients are followed at 4 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 135 patients will be accrued for this study within 44 months
Compare the 3-year survival of patients with high-risk low-grade gliomas treated with temozolomide and radiotherapy followed by temozolomide alone with that of patients enrolled on European Organization for Research and Treatment of Cancer EORTCclinical trials EORTC-22844 and EORTC-22845
Determine the toxicity of this regimen in these patients
Determine the association between progression-free survival and O6-methylguanine-DNA methyltransferase MGMT methylation status in patients treated with this regimen
Determine the association between survival and MGMT methylation status in patients treated with this regimen
Determine the quality of life QOL of patients treated with this regimen
Determine the neurocognitive function of patients treated with this regimen
Evaluate the feasibility of collecting patient-reported QOL and neurocognitive assessments over 3 years
OUTLINE This is a non-randomized multicenter study
Patients receive oral temozolomide once daily on days 1-42 and undergo radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 and 36-40 one hour before RT weekdays in the evening weekends Beginning 28 days after completion of chemoradiotherapy patients receive oral temozolomide once daily on days 1-5 Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 6 months 12 months
After completion of study treatment patients are followed at 4 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 135 patients will be accrued for this study within 44 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 |
|---|---|---|---|
| NCI-2009-00723 | REGISTRY | CTRP Clinical Trial Reporting Program | None |
| CDR0000434849 | None | None | None |