Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024336
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2001-09-13
Brief Title:
Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Tamoxifen may kill tumor cells by blocking the enzymes necessary for cell growth Combining radiation therapy with tamoxifen may be effective in treating newly diagnosed brain stem glioma
PURPOSE Phase II trial to study the effectiveness of combining radiation therapy and tamoxifen in treating children who have newly diagnosed brain stem glioma
PURPOSE Phase II trial to study the effectiveness of combining radiation therapy and tamoxifen in treating children who have newly diagnosed brain stem glioma
Detailed Description:
OBJECTIVES
Determine whether high-dose tamoxifen with radiotherapy increases the median survival and overall survival of children with newly diagnosed brain stem gliomas
Determine the time to neurologic or radiographic progression in patients treated with this regimen
Determine the acute and chronic toxicity of high-dose tamoxifen in these patients
OUTLINE This is a multicenter study
Patients undergo radiotherapy once daily 5 days a week for 6 weeks Within 2 weeks after the initiation of radiotherapy patients receive oral high-dose tamoxifen once daily Tamoxifen continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 60 patients will be accrued for this study within 4 years
Determine whether high-dose tamoxifen with radiotherapy increases the median survival and overall survival of children with newly diagnosed brain stem gliomas
Determine the time to neurologic or radiographic progression in patients treated with this regimen
Determine the acute and chronic toxicity of high-dose tamoxifen in these patients
OUTLINE This is a multicenter study
Patients undergo radiotherapy once daily 5 days a week for 6 weeks Within 2 weeks after the initiation of radiotherapy patients receive oral high-dose tamoxifen once daily Tamoxifen continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 60 patients will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20123 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068920 | REGISTRY | None | None |