Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028678
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2002-01-04
Brief Title:
Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study to Evaluate the Effect of Dalteparin and Radiation Therapy on Survival Compared to the RTOG RPA Database and on Thromboembolic Events in Patients With Newly Diagnosed Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2023-06
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 Dalteparin may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth Radiation therapy uses high-energy x-rays to damage tumor cells Combining dalteparin with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining dalteparin with radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of combining dalteparin with radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine whether dalteparin initiated at the time of conventional radiotherapy improves the median survival of patients with newly diagnosed supratentorial glioblastoma multiforme
Determine the time to progression in patients treated with this regimen
Determine the incidence of thromboembolic events in patients treated with this regimen
Determine the feasibility and toxicity of dalteparin in this patient population
OUTLINE This is a multicenter study
Patients undergo cranial irradiation 5 days a week for 7 weeks Beginning concurrently with initiation of radiotherapy patients receive dalteparin subcutaneously once daily for up to 2 years in the absence of unacceptable toxicity Patients may continue receiving dalteparin after year 2 at the discretion of the investigator
Patients are followed every 3 months for 2 years and then every 6 months for up to 5 years after study entry
PROJECTED ACCRUAL A total of 72 patients will be accrued for this study
Determine whether dalteparin initiated at the time of conventional radiotherapy improves the median survival of patients with newly diagnosed supratentorial glioblastoma multiforme
Determine the time to progression in patients treated with this regimen
Determine the incidence of thromboembolic events in patients treated with this regimen
Determine the feasibility and toxicity of dalteparin in this patient population
OUTLINE This is a multicenter study
Patients undergo cranial irradiation 5 days a week for 7 weeks Beginning concurrently with initiation of radiotherapy patients receive dalteparin subcutaneously once daily for up to 2 years in the absence of unacceptable toxicity Patients may continue receiving dalteparin after year 2 at the discretion of the investigator
Patients are followed every 3 months for 2 years and then every 6 months for up to 5 years after study entry
PROJECTED ACCRUAL A total of 72 patients will be accrued for this study
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 |
|---|---|---|---|
| E1F01 | None | None | None |