Image Guided Reirradiation of High-grade Glioma

Image Guided Reirradiation of High-grade Glioma - a Phase I/II Dose Escalation Study

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 Overview

• Status: Terminated
• Conditions: Glioblastoma; Malignant Glioma
• Intervention / Treatment: Radiation: External beam radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Radiation Oncology, Rigshospitalet
• Sweden
  • Lund, Sweden, 22185
    • Skanes universitetssjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: External beam radiotherapy; Hypofractionated external beam radiation delivered in 4 different sequential dose/fractionation groups.

Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Rate of objective tumor responses following treatment evaluated by RANO criteria and by 18F-FET-PET.	Up to one year

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Danish Center for Interventional Research in Radiation Oncology (CIRRO)
• Investigators: Study Chair: Svend Aage Engelholm, MD, Department of Radiation Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 27, 2013
• First Posted (Estimate): December 31, 2013

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: positron emission tomography; recurrent glioma; reirradiation; amino acid tracer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma
• Other Study ID Numbers: RH ReRT 2011; H-2-2011-092 (Registry Identifier: Capital Region Commitee on Health Research Ethics)