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| ID | Type | Description | Link |
|---|---|---|---|
| H-2-2011-092 | Registry Identifier | Capital Region Commitee on Health Research Ethics |
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Slow accrual
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| Name | Class |
|---|---|
| Danish Center for Interventional Research in Radiation Oncology (CIRRO) | OTHER |
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The purpose of the study is to evaluate the short- and long term toxicity of radiotherapy to patients with recurrent high-grade glioma who have previously received radiotherapy and to determine the best dose and treatment regimen. Positron emission tomography (PET) using an amino acid tracer, 18-fluoro-ethyltyrosine (18F-FET), is used for target delineation.The study examines, in four sequential treatment groups, the effect of dose, hypofractionation and treatment volume on toxicity. Upon completion of the phase I part, the study progresses to phase II where the best dose- and treatment regimen will be chosen for treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| External beam radiotherapy | Experimental | Hypofractionated external beam radiation delivered in 4 different sequential dose/fractionation groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External beam radiotherapy | Radiation | Study group 1: 3.5 Gray x 10, 5 fractions per week. Study group 2: 3.5 Gray x 10 + 7 Gray boost to biological target volume, 5 fractions per week. Study group 3: 5.9 Gray x 10, 5 fractions per week. Study group 4 (planning target volumes: 100 millilitres - 300 millilitres): 3.5 Gray x 10, 5 fractions per week. Phase II dosis: to be chosen based on results of phase I study. |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Early (<4 weeks) and late (> 4 weeks) toxicity evaluated by Common Toxicity Criteria ver. 3.0 at multiple time points up to one year after treatment. (for phase I part of the study) | One year |
| Diagnostic precision of 18F-FET-PET imaging in recurrent high-grade glioma | Diagnostic accuracy (positive- and negative predictive value) of 18F-FET-PET guided biopsies (optional procedure) in patients who will receive reirradiation for recurrent high-grade glioma in the study. (for phase I part of the study). | Approximately one to two weeks prior to radiotherapy |
| Time to neurocognitive decline | Time to neurocognitive decline assessed using a test battery comprised of validated tests at multiple time points. (for phase II part of the study) | Up to one year |
| Time to progression | Time to disease progression evaluated by RANO (Response Assessment in Neuro-Oncology) criteria (for phase II part of the study). | Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Value of 18F-FET-PET in reirradiation of high-grade glioma | Prognostic value of 18F-FET-PET scan at baseline, value of 18F-FET-PET as an early response marker and correlations between 18F-FET-PET scans and magnetic resonance imaging. | One year |
| Objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Svend Aage Engelholm, MD | Department of Radiation Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Skånes universitetssjukhus |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Rate of objective tumor responses following treatment evaluated by RANO criteria and by 18F-FET-PET. |
| Up to one year |
| Lund |
| 22185 |
| Sweden |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |