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Recurrent Glioma (Glioblastoma Multiforme)Phase 2GLIAANCT01252459

Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme

A Phase 2 study testing Radiation Therapy in people with Recurrent Glioma (Glioblastoma Multiforme), run by University Hospital Freiburg at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is designed to evaluate the impact of radiotherapy target volume delineation based on AA-PET compared to target volume delineation based on contrast enhanced T1 weighted MRI (T1Gd-MRI) on the clinical outcome of patients with recurrent glioblastoma (GBM) as well as concerning therapeutic safety of the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteGermany
Study dates
Jul 2011to Jul 2014
Phase
Phase 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

  • Local recurrence of GBM (WHO grade IV) and either not eligible for tumor resection or with macroscopic residual tumor after resection of recurrent GBM
  • Recurrent tumor visible on AA-PET and MRI-T1-Gd with the diameter measuring 1 cm to 6 cm by either technique
  • Target volume definition possible according to both study arms
  • Previous radiation therapy of the primary with a maximal total dose 60 Gy
  • At least 9 months since the end of pre-irradiation and randomisation
  • At most 2 prior chemotherapy regimes
Show all 10Show fewer
  • Start of radiation therapy possible within 2 weeks from AA-PET
  • Karnofsky Performance Score (KPS) ≥ 70%
  • Age ≥ 18 years
  • Written informed consent (IC) obtained

Who cannot join

  • - No histological confirmation of Glioma at initial diagnosis)
  • Recent (≤ 4 weeks before IC) histological result showing no tumor recurrence
  • No recurrent tumor detectable on last AA-PET or MRI-T1-Gd
  • Technical impossibility to use existing AA-PET for RT-planning
  • No prior radiation treatment to the primary tumor
  • less than 9 months between the end of first radiation treatment and randomisation
Show all 10Show fewer
  • more than 2 previous chemotherapy regimes or previous treatment with Avastin or other molecular targeted therapies
  • less than 2 weeks between application of chemotherapy and randomisation
  • additional chemotherapy or molecular targeted therapy or further surgery planned before diagnosis of further tumor progression after study intervention
  • pregnancy, nursing or patient not willing to prevent pregnancy during treatment

Trial locations and contacts

1 site in 1 country.

Anca-Ligia Grosu, Prof. Dr. med. contact

0049-761-270 ext. 9520

gliaa@uniklinik-freiburg.de

Ursula Nestle, PD Dr. med. contact

0049-761-270 ext. 9520

gliaa@uniklinik-freiburg.de

Germany1 site

  • Department of Radiotherapy, University Hospital Freiburg

    Freiburg I. Br., Baden-Wurttemberg, 79106

    Nicole Wiedenmann, Dr. med.

    Marianne Schmucker, Dr. med.

Other trials in Germany

About this study

Official title: Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme - a Randomised Phase II Trial

This study is designed to evaluate the impact of radiotherapy target volume delineation based on AA-PET compared to target volume delineation based on contrast enhanced T1 weighted MRI (T1Gd-MRI) on the clinical outcome of patients with recurrent glioblastoma (GBM) as well as concerning therapeutic safety of the respective strategy.

Read the detailed description

The higher sensitivity and specificity of amino-acids (L-[methyl-11C]-methionine, MET and O-(2-(1)-Fluoroethyl)-L-tyrosine, FET) positron emission tomography (AA-PET) in the diagnosis of gliomas in comparison to computed tomography (CT) and magnetic resonance imaging (MRI) was demonstrated in many studies and is the rationale for using them in target volume delineation of these tumors. Several clinical trials have demonstrated the significant differences between AA-PET and standard MRI in gross tumor volume (GTV) delineation for treatment planning.

A small prospective study in patients with recurrent high grade gliomas treated with stereotactic fractionated radiotherapy (SFRT) showed a significant improvement in survival when AA-PET or single photon emission tomography (AA-SPECT) were integrated in target volume delineation, in comparison to patients treated using CT/MRI alone (Grosu et al. 2005).

However, there are no randomized studies demonstrating the impact of AA-PET based irradiation treatment on the clinical follow-up in comparison to a traditional MRI/CT based treatment.

The goal of this study is to evaluate the impact of radiotherapy target volume delineation based on AA-PET (new strategy) on the clinical outcome of patients with recurrent glioblastoma (GBM) compared to target volume delineation based on contrast enhanced T1 weighted MRI (T1Gd-MRI) (traditional, established strategy). Concerning therapeutic safety, the topography of recurrence outside the primary target volume as well as the localization of necrosis after the re-irradiation will be determined. All side effects will be assessed by CTCAE version 4.0 and the safety analyses will present the worst grade of acute and late side effect by treatment arm for the whole study period (treatment and follow up). Patients will be asked to complete a quality of life (QoL) questionnaire (as assessed by the E-ORTC QLQ-C15 PAL) in regular time intervals.

This will be the first phase II randomized study evaluating the impact of molecular imaging on outcome after radiotherapy in brain tumor patients.

Another goal of the technical part of this study is the development of a standardized physical-technical methodology for the integration of AA-PET and other imaging biomarkers in tumor volume delineation in radiation therapy.

Being tested
Radiation Therapy
Keywords
AA-PET, T1-Gd-MRI, re-irradiation, recurrent glioma
Medical subject headings
Glioblastoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation TherapyRadiation

    Experimental intervention (Arm A): High-precision re-irradiation (stereotactic fractionated radiation therapy (SFRT) and/or image guided radiation therapy, (IGRT), total dose 39 Gy, 3 Gy/d, 5x/ week. Target volume delineation based on AA-PET: GTV = AA uptake on PET, clinical target volume (CTV) = GTV+3mm, PTV = CTV+2mm

  • Radiation TherapyRadiation

    Control intervention (Arm B): High-precision re-irradiation (SFRT and/or IGRT), total dose 39 Gy, 3 Gy/d, 5x/ week. Target volume delineation based on T1Gd-MRI: GTV = contrast enhancement on T1Gd-MRI, CTV = GTV+3mm, PTV = CTV+2mm

Study groups in NCT01252459
Study groupRoleWhat they receive
Arm A: AA-PET based target volume delineationExperimentalExperimental intervention (Arm A): High-precision re-irradiation. Target volume delineation based on AA-PET.
Receives: Radiation: Radiation Therapy
Arm B: T1Gd-MRI based target volume delineationActive comparatorControl intervention (Arm B): High-precision re-irradiation. Target volume delineation based on T1Gd-MRI.
Receives: Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Measured: 6 months after randomization

Secondary outcomes (7)

  1. Overall survival

    Kaplan-Meier: Performed on the per protocol population - all patients who are eligible and have started their allocated treatment

    Measured: 1 year after randomisation

  2. Volumetrical assessment of GTV and PTV

    Volumetrical assessment of delineated gross tumor volume (GTV) and planning target volume (PTV) based on AA-PET vs. delineated GTV/PTV based on T1-Gd-MRI.

    Measured: Interim analysis

  3. Topography of recurrence

    local relationship between recurrence and AA-PEt and MRI-derived TV

    Measured: Follow up (end of radiotherapy, 6 and 12 weeks after radiotherapy, then every 3 months)

  4. Localisation of necrosis after re-irradiation

    Measured: Follow up (end of radiotherapy, 6 and 12 weeks after radiotherapy, then every 3 months)

  5. Rate of long-term survivors

    Rate of long-term survivors = Survivors > 1 year after randomisation

    Measured: Follow up

  6. Quality of Life (QoL)

    QoL assessed by the EORTC QlQ-C 15 PAL questionnaire

    Measured: During Radiotherapy and Follow Up

  7. Rate of side effects

    Assessed according to CTCAE

    Measured: During Radiotherapy and Follow Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2010 (estimated)
  2. Study startJul 2011
  3. Primary completionJul 2013 (estimated)
  4. Study completionJul 2014 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01252459
Sponsor's protocol ID
AG NUK/RT 2010-1
Acronym
GLIAA
Status last verified
Dec 2010
First submitted
2 Dec 2010
Last updated
16 Dec 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Grosu AL, Weber WA. PET for radiation treatment planning of brain tumours. Radiother Oncol. 2010 Sep;96(3):325-7. doi: 10.1016/j.radonc.2010.08.001. Epub 2010 Aug 20.

    PubMed 20728952

  • Grosu AL, Weber WA, Franz M, Stark S, Piert M, Thamm R, Gumprecht H, Schwaiger M, Molls M, Nieder C. Reirradiation of recurrent high-grade gliomas using amino acid PET (SPECT)/CT/MRI image fusion to determine gross tumor volume for stereotactic fractionated radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):511-9. doi: 10.1016/j.ijrobp.2005.01.056.

    PubMed 16168843

  • Grosu AL, Weber WA, Riedel E, Jeremic B, Nieder C, Franz M, Gumprecht H, Jaeger R, Schwaiger M, Molls M. L-(methyl-11C) methionine positron emission tomography for target delineation in resected high-grade gliomas before radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):64-74. doi: 10.1016/j.ijrobp.2005.01.045.

    PubMed 16111573

  • Grosu AL, Piert M, Weber WA, Jeremic B, Picchio M, Schratzenstaller U, Zimmermann FB, Schwaiger M, Molls M. Positron emission tomography for radiation treatment planning. Strahlenther Onkol. 2005 Aug;181(8):483-99. doi: 10.1007/s00066-005-1422-7.

    PubMed 16044216

  • Grosu AL, Lachner R, Wiedenmann N, Stark S, Thamm R, Kneschaurek P, Schwaiger M, Molls M, Weber WA. Validation of a method for automatic image fusion (BrainLAB System) of CT data and 11C-methionine-PET data for stereotactic radiotherapy using a LINAC: first clinical experience. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1450-63. doi: 10.1016/s0360-3016(03)00279-7.

    PubMed 12873691

  • Grosu AL, Feldmann H, Dick S, Dzewas B, Nieder C, Gumprecht H, Frank A, Schwaiger M, Molls M, Weber WA. Implications of IMT-SPECT for postoperative radiotherapy planning in patients with gliomas. Int J Radiat Oncol Biol Phys. 2002 Nov 1;54(3):842-54. doi: 10.1016/s0360-3016(02)02984-x.

    PubMed 12377338

  • Weber WA, Wester HJ, Grosu AL, Herz M, Dzewas B, Feldmann HJ, Molls M, Stocklin G, Schwaiger M. O-(2-[18F]fluoroethyl)-L-tyrosine and L-[methyl-11C]methionine uptake in brain tumours: initial results of a comparative study. Eur J Nucl Med. 2000 May;27(5):542-9. doi: 10.1007/s002590050541.

    PubMed 10853810

  • Grosu AL, Weber W, Feldmann HJ, Wuttke B, Bartenstein P, Gross MW, Lumenta C, Schwaiger M, Molls M. First experience with I-123-alpha-methyl-tyrosine spect in the 3-D radiation treatment planning of brain gliomas. Int J Radiat Oncol Biol Phys. 2000 May 1;47(2):517-26. doi: 10.1016/s0360-3016(00)00423-5.

    PubMed 10802381

  • Grosu AL, Weber WA, Graf E, Mix M, Nestle U, Schimek-Jasch T, Wiehle R, Mader I, Wurtemberger U, Langen KJ, Niyazi M, Paulsen F, Konig L, Giordano FA, Spehl I, Bernhardt D, Schymalla MM, Pottgen C, Semrau S, Brunner T, Hultenschmidt B, Krause BJ, Ciernik IF, Beck J, Baumert BG, Meyer PT, Urbach H, Popp I; GLIAA Study Group. O-(2-[18F]fluoroethyl)-L-tyrosine-PET-guided versus contrast-enhanced T1-weighted MRI-guided re-irradiation in patients with recurrent glioblastoma (GLIAA/NOA-10 ARO2013-01): a multicentre, open-label, randomised trial. Lancet Oncol. 2026 Feb;27(2):169-180. doi: 10.1016/S1470-2045(25)00642-4. Epub 2025 Dec 19.

    PubMed 41429128

  • Oehlke O, Mix M, Graf E, Schimek-Jasch T, Nestle U, Gotz I, Schneider-Fuchs S, Weyerbrock A, Mader I, Baumert BG, Short SC, Meyer PT, Weber WA, Grosu AL. Amino-acid PET versus MRI guided re-irradiation in patients with recurrent glioblastoma multiforme (GLIAA) - protocol of a randomized phase II trial (NOA 10/ARO 2013-1). BMC Cancer. 2016 Oct 5;16(1):769. doi: 10.1186/s12885-016-2806-z.

    PubMed 27716184

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation Therapy in people with Recurrent Glioma (Glioblastoma Multiforme), run by University Hospital Freiburg at 1 site in Germany.

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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 phase mean?

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anca-Ligia Grosu, Prof. Dr. med. (0049-761-270 ext. 9520, gliaa@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01252459, which also lists 10 linked publications.

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 16 Dec 2010.

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