Clinical trial · Interventional
Image Guided Reirradiation of High-grade Glioma
Image Guided Reirradiation of High-grade Glioma - a Phase I/II Dose Escalation Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External beam radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- External beam radiotherapy
- description
- Hypofractionated external beam radiation delivered in 4 different sequential dose/fractionation groups.
- interventionNames
- Radiation: External beam radiotherapy
Primary outcomes (4)
- measure
- Toxicity
- timeFrame
- One year
- description
- 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)
- measure
- Diagnostic precision of 18F-FET-PET imaging in recurrent high-grade glioma
- timeFrame
- Approximately one to two weeks prior to radiotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * recurrent high-grade glioma * previous focal radiotherapy for high-grade glioma * no standard treatment options available/indicated * ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 or 2 * life expectancy \> 3 months * hemoglobin value \> 6 mmol/l (transfusion permitted) * able to understand oral and written Danish Exclusion Criteria: * disseminated recurrent disease * infection or wound dehiscence or other pathological condition in meninges/skull/scalp * symptoms of elevated intracranial pressure * very early recurrence following primary radiotherapy (\< or equal to 3 months) * contraindications to magnetic resonance imaging (MRI) or positron emission tomography (PET) * other previous radiotherapy to the brain than primary course of irradiation
References
Publications (0)
Data not yet available