NCT02025231

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2011

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

3.3 years

First QC Date

December 18, 2013

Last Update Submit

February 6, 2017

Conditions

Malignant GliomaGlioblastoma

Keywords

reirradiationrecurrent gliomapositron emission tomographyamino acid tracer

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Value of 18F-FET-PET in reirradiation of high-grade glioma

    One year

  • Objective response rate

    Up to one year

Study Arms (1)

External beam radiotherapy

EXPERIMENTAL

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

Radiation: External beam radiotherapy

Interventions

External beam radiotherapyRADIATION

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.

External beam radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Radiation Oncology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Skånes universitetssjukhus

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

GliomaGlioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAstrocytoma

Study Officials

  • Svend Aage Engelholm, MD

    Department of Radiation Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 18, 2013

First Posted

December 31, 2013

Study Start

December 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

SE(1)DK(1)