Malignant GliomaPhase 1/2NCT02025231
Image Guided Reirradiation of High-grade Glioma
A Phase 1/2 study testing External beam radiotherapy in people with Malignant Glioma and Glioblastoma, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma, Glioblastoma
- What is being tested?
- External beam radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2011to Apr 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site
Department of Radiation Oncology, Rigshospitalet
Copenhagen, 2100
About this study
Official title: 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.
- Conditions
- Malignant Glioma, Glioblastoma
- Being tested
- External beam radiotherapy
- Keywords
- reirradiation, recurrent glioma, positron emission tomography, amino acid tracer
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| External beam radiotherapy | Experimental | Hypofractionated external beam radiation delivered in 4 different sequential dose/fractionation groups. Receives: Radiation: External beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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)
Measured: 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).
Measured: Up to one year
Secondary outcomes (2)
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.
Measured: One year
Objective response rate
Rate of objective tumor responses following treatment evaluated by RANO criteria and by 18F-FET-PET.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startDec 2011
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Center for Interventional Research in Radiation Oncology (CIRRO)
- Responsible party
- Principal investigator, Søren Møller, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Svend Aage Engelholm, MD, Study chair, Department of Radiation Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025231
- Sponsor's protocol ID
- RH ReRT 2011
- Other IDs
- H-2-2011-092
- Status last verified
- Feb 2017
- First submitted
- 18 Dec 2013
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Guided Reirradiation of High-grade Glioma - a Phase I/II Dose Escalation Study
- ClinicalTrials.gov ID
- NCT02025231
- Acronym / sponsor ID
- RH ReRT 2011
- Conditions
- Malignant Glioma, Glioblastoma
- Keywords
- reirradiation, recurrent glioma, positron emission tomography, amino acid tracer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Center for Interventional Research in Radiation Oncology (CIRRO)
- Study start
- Dec 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| External beam radiotherapy | Experimental | Radiation: External beam radiotherapyHypofractionated external beam radiation delivered in 4 different sequential dose/fractionation groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External beam radiotherapyStudy 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. | Radiation | External beam radiotherapy |
Primary outcome
Toxicity
Time frame: One year
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
Time frame: Approximately one to two weeks prior to radiotherapy
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 frame: Up to one year
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 frame: Up to one year
Time to disease progression evaluated by RANO (Response Assessment in Neuro-Oncology) criteria (for phase II part of the study).
2 secondary outcomes
Value of 18F-FET-PET in reirradiation of high-grade glioma
Time frame: One year
Objective response rate
Time frame: Up to one year
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svend Aage Engelholm, MD study chair
Department of Radiation Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing External beam radiotherapy in people with Malignant Glioma and Glioblastoma, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.