Clinical trial · Observational
The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas
NCT00473408CI-TRIAL-00025022GliomstudienterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Moved to another country, not possible to recruit from abroad.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Tumor Angiogenesis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Procedure | — | UNRESOLVED |
| Functional MRI (DCE-MRI) | Device | — | UNRESOLVED |
| Tumor sample | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* 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 Criteria:
* Lack of fulfillment of inclusion criteria.References
Publications (4)
- BACKGROUNDCao Y, Sundgren PC, Tsien CI, Chenevert TT, Junck L. Physiologic and metabolic magnetic resonance imaging in gliomas. J Clin Oncol. 2006 Mar 10;24(8):1228-35. doi: 10.1200/JCO.2005.04.7233. PMID 16525177
- BACKGROUNDMorgan B, Thomas AL, Drevs J, Hennig J, Buchert M, Jivan A, Horsfield MA, Mross K, Ball HA, Lee L, Mietlowski W, Fuxuis S, Unger C, O'Byrne K, Henry A, Cherryman GR, Laurent D, Dugan M, Marme D, Steward WP. Dynamic contrast-enhanced magnetic resonance imaging as a biomarker for the pharmacological response of PTK787/ZK 222584, an inhibitor of the vascular endothelial growth factor receptor tyrosine kinases, in patients with advanced colorectal cancer and liver metastases: results from two phase I studies. J Clin Oncol. 2003 Nov 1;21(21):3955-64. doi: 10.1200/JCO.2003.08.092. Epub 2003 Sep 29. PMID 14517187
- BACKGROUNDMancuso P, Rabascio C, Bertolini F. Strategies to investigate circulating endothelial cells in cancer. Pathophysiol Haemost Thromb. 2003 Sep-2004 Dec;33(5-6):503-6. doi: 10.1159/000083853. PMID 15692268
- BACKGROUNDSingh SK, Hawkins C, Clarke ID, Squire JA, Bayani J, Hide T, Henkelman RM, Cusimano MD, Dirks PB. Identification of human brain tumour initiating cells. Nature. 2004 Nov 18;432(7015):396-401. doi: 10.1038/nature03128. PMID 15549107