Status:
TERMINATED
The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
University of Bergen
Conditions:
Anaplastic Astrocytoma
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
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 effe...
Detailed Description
Today's standard treatment with radiotherapy and temozolomide yields a life expectancy of 1.5-3 years in patients with high-grade astrocytomas. Thus, there is a need for further therapeutic improvemen...
Eligibility Criteria
Inclusion
- Histologically confirmed primary high-grade astrocytoma, i.e. anaplastic astrocytoma or glioblastoma multiforme.
- Have a WHO performance status 0-2 and be able to undergo outpatient treatment.
- Age ≥18 years.
- No pregnant or lactating patients can be included.
- Patients must have radiographically documented measurable disease postoperatively. At least one tumor lesion must be unidimensionally measurable as follows:
- Tumor lesion \> 10 mm on conventional MRI scan, T1-weighted series, after intravenous (i.v.) gadolinium chelate contrast.
- All diagnostic radiology studies must be performed within 28 days prior to registration.
- Absence of conditions making MRI scans impossible;
- Cardiac pacemaker
- Other ferromagnetic metal implants not authorised for use in MRI such as some types of cerebral aneurysm clips
- Serious claustrophobia
- Obesity (\> 300 lb., 140 Kg)
- Patients who are receiving corticosteroids have to receive stable or decreasing doses for at least 14 days before entering the trial.
- No prior chemotherapy for high-grade astrocytoma
- Absence of opportunistic infections making temozolomide contraindicated.
- Minimum required laboratory data:
- Hematology:
- Absolute granulocytes \> 1.0 x 10\^9/L
- Platelets \> 100 x 10\^9/L
- Biochemistry:
- Bilirubin \< 1.5 x upper normal limit
- INR \< 1.5
- Serum creatinine \<1.5 x upper normal limit
- Adequate cognitive function in order to give informed consent.
- Absence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration/randomization, written informed consent must be given according to national and local regulations.
Exclusion
- Lack of fulfillment of inclusion criteria.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00473408
Start Date
March 1 2007
End Date
November 1 2011
Last Update
December 6 2016
Active Locations (1)
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1
Dept. of Oncology & Dept. of Radiology, Haukeland University Hospital
Bergen, Norway, Hordaland, Norway, 5021