Image Guided Reirradiation of High-grade Glioma

Phase 1

Terminated

• Conditions: Glioblastoma; Malignant Glioma
• Interventions: Radiation: External beam radiotherapy

• Registration Number: NCT02025231
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2013-12-31
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
External beam radiotherapy	External beam radiotherapy	Hypofractionated external beam radiation delivered in 4 different sequential dose/fractionation groups.

Primary Outcome Measures

Name	Time	Method
Time to neurocognitive decline	Up to one year	Time to neurocognitive decline assessed using a test battery comprised of validated tests at multiple time points. (for phase II part of the study)
Toxicity	One year	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)
Diagnostic precision of 18F-FET-PET imaging in recurrent high-grade glioma	Approximately one to two weeks prior to radiotherapy	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).
Time to progression	Up to one year	Time to disease progression evaluated by RANO (Response Assessment in Neuro-Oncology) criteria (for phase II part of the study).

Secondary Outcome Measures

Name	Time	Method
Objective response rate	Up to one year	Rate of objective tumor responses following treatment evaluated by RANO criteria and by 18F-FET-PET.
Value of 18F-FET-PET in reirradiation of high-grade glioma	One year	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.

Trial Locations

Locations (2)

Skånes universitetssjukhus; 🇸🇪 Lund, Sweden

Department of Radiation Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark