Overview

This trial is active, not recruiting.

Conditions malignant glioma, glioblastoma
Treatment external beam radiotherapy
Phase phase 1/phase 2
Sponsor Rigshospitalet, Denmark
Collaborator Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Start date December 2011
End date July 2015
Trial size 45 participants
Trial identifier NCT02025231, H-2-2011-092, RH ReRT 2011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Hypofractionated external beam radiation delivered in 4 different sequential dose/fractionation groups.
external beam radiotherapy
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.

Primary Outcomes

Measure
Toxicity
time frame: One year
Diagnostic precision of 18F-FET-PET imaging in recurrent high-grade glioma
time frame: Approximately one to two weeks prior to radiotherapy
Time to neurocognitive decline
time frame: Up to one year
Time to progression
time frame: Up to one year

Secondary Outcomes

Measure
Value of 18F-FET-PET in reirradiation of high-grade glioma
time frame: One year
Objective response rate
time frame: Up to one year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Image Guided Reirradiation of High-grade Glioma - a Phase I/II Dose Escalation Study
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.