Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473408
Status:
TERMINATED
Last Update Posted:
2016-12-06
First Post:
2007-05-14
Brief Title:
The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Moved to another country not possible to recruit from abroad
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Gliomstudien
Brief Summary:
The purpose of the current trial is to explore whether the standard treatment with radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade astrocytomas If vascular effects are identified future clinical trials can be proposed wherein anti-angiogenic agents are added to increase patient survival
Detailed Description:
Todays standard treatment with radiotherapy and temozolomide yields a life expectancy of 15-3 years in patients with high-grade astrocytomas Thus there is a need for further therapeutic improvements in this patient population The purpose of the current trial is to explore whether radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade astrocytomas If vascular effects are identified future clinical trials can be proposed wherein anti-angiogenic agents are added to increase patient survival Additionally stem cells within malignant brain tumors is an important new area of research in this patient population and investigations herein could contribute to identify new predictive markers and therapeutic targets
Primary objective To assess the vascular perfusion and permeability characteristics of high-grade astrocytomas anaplastic astrocytoma and glioblastoma multiforme using dynamic contrast-enhanced magnetic resonance imaging DCE-MRI in patients receiving radiotherapy and temozolomide Furthermore to assess whether therapy-induced changes in tumor perfusion is correlated with progression-free survival
Secondary objectives
Analyze circulating endothelial cells in the blood by flow cytometry to explore whether these cells can be used as an indirect estimate of angiogenesis in high-grade astrocytomas
Analyze tumor specimens from patients that have had their gliomas debulked before commencing therapy
immunostaining of the tumor vasculature to assess microvessel density
immunostaining for tumor stem cells
flow cytometric assessment of dissolved tumor tissue to look for tumor stem cells
Assess progression-free survival of all patients included in the study in order to correlate the survival data with the above tissue sampling results
Primary objective To assess the vascular perfusion and permeability characteristics of high-grade astrocytomas anaplastic astrocytoma and glioblastoma multiforme using dynamic contrast-enhanced magnetic resonance imaging DCE-MRI in patients receiving radiotherapy and temozolomide Furthermore to assess whether therapy-induced changes in tumor perfusion is correlated with progression-free survival
Secondary objectives
Analyze circulating endothelial cells in the blood by flow cytometry to explore whether these cells can be used as an indirect estimate of angiogenesis in high-grade astrocytomas
Analyze tumor specimens from patients that have had their gliomas debulked before commencing therapy
immunostaining of the tumor vasculature to assess microvessel density
immunostaining for tumor stem cells
flow cytometric assessment of dissolved tumor tissue to look for tumor stem cells
Assess progression-free survival of all patients included in the study in order to correlate the survival data with the above tissue sampling results
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 |
|---|---|---|---|
| REK ID 20206 | REGISTRY | Regional Ethics Committee | None |