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Image Guided Reirradiation of High-grade Glioma

Primary Purpose

Malignant Glioma, Glioblastoma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
External beam radiotherapy
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Glioma focused on measuring reirradiation, recurrent glioma, positron emission tomography, amino acid tracer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Radiation Oncology, Rigshospitalet
  • Skånes universitetssjukhus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

External beam radiotherapy

Arm Description

Hypofractionated external beam radiation delivered in 4 different sequential dose/fractionation groups.

Outcomes

Primary Outcome Measures

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)
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 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 to progression
Time to disease progression evaluated by RANO (Response Assessment in Neuro-Oncology) criteria (for phase II part of the study).

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2013
Last Updated
February 6, 2017
Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
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1. Study Identification

Unique Protocol Identification Number
NCT02025231
Brief Title
Image Guided Reirradiation of High-grade Glioma
Official Title
Image Guided Reirradiation of High-grade Glioma - a Phase I/II Dose Escalation Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Center for Interventional Research in Radiation Oncology (CIRRO)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma, Glioblastoma
Keywords
reirradiation, recurrent glioma, positron emission tomography, amino acid tracer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External beam radiotherapy
Arm Type
Experimental
Arm Description
Hypofractionated external beam radiation delivered in 4 different sequential dose/fractionation groups.
Intervention Type
Radiation
Intervention Name(s)
External beam radiotherapy
Intervention Description
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 Outcome Measure Information:
Title
Toxicity
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)
Time Frame
One year
Title
Diagnostic precision of 18F-FET-PET imaging in recurrent high-grade glioma
Description
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
Title
Time to neurocognitive decline
Description
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
Title
Time to progression
Description
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 Outcome Measure Information:
Title
Value of 18F-FET-PET in reirradiation of high-grade glioma
Description
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
Title
Objective response rate
Description
Rate of objective tumor responses following treatment evaluated by RANO criteria and by 18F-FET-PET.
Time Frame
Up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svend Aage Engelholm, MD
Organizational Affiliation
Department of Radiation Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Radiation Oncology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Skånes universitetssjukhus
City
Lund
ZIP/Postal Code
22185
Country
Sweden

12. IPD Sharing Statement

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Image Guided Reirradiation of High-grade Glioma

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