Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006388
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2000-10-04
Brief Title:
Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Trial of High Dose Tamoxifen For The Treatment of Newly Diagnosed Supratentorial Glioblastoma Multiforme GBM
Status:
COMPLETED
Status Verified Date:
2015-11
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 such as tamoxifen may make the tumor cells more sensitive to radiation therapy
PURPOSE Phase II trial to study the effectiveness of combining radiation therapy with tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of combining radiation therapy with tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma multiforme
Detailed Description:
OBJECTIVES I Determine whether high-dose tamoxifen initiated at the beginning of conventional radiotherapy improves the median survival time of adults with newly diagnosed supratentorial glioblastoma multiforme II Determine the feasibility and toxicity of high-dose tamoxifen in these patients III Determine the overall survival with respect to protein kinase C lab correlates in patients treated with this regimen
OUTLINE This is a multicenter study Beginning within 5 weeks after surgery patients undergo radiotherapy to the brain 5 days a week for 6 weeks Patients receive high-dose oral tamoxifen every 6 hours beginning on day 1 of radiotherapy and continuing in the absence of disease progression Patients are followed every 3 months through year 1 every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 72 patients will be accrued for this study within 6 months
OUTLINE This is a multicenter study Beginning within 5 weeks after surgery patients undergo radiotherapy to the brain 5 days a week for 6 weeks Patients receive high-dose oral tamoxifen every 6 hours beginning on day 1 of radiotherapy and continuing in the absence of disease progression Patients are followed every 3 months through year 1 every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 72 patients will be accrued for this study within 6 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 |
|---|---|---|---|
| CDR0000068266 | None | None | None |