Image Guided Reirradiation of High-grade Glioma

Phase 2TerminatedNCT02025231

Rigshospitalet, Denmark31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Glioma Glioblastoma

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Department of Radiation Oncology, Rigshospitalet

Copenhagen, Denmark

Skånes universitetssjukhus

Lund, Sweden

Outcomes

Primary Outcomes

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)

Time frame: 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).

Time frame: 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)

Time frame: 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).

Time frame: Up to one year

Secondary Outcomes

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.

Time frame: One year

Objective response rate

Rate of objective tumor responses following treatment evaluated by RANO criteria and by 18F-FET-PET.

Time frame: Up to one year