Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme - a Randomised Phase II Trial
18 Years
N/A
Both
Recurrent Glioma (Glioblastoma Multiforme)
Trial Information
Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme - a Randomised Phase II Trial
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.
Inclusion Criteria:
- 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
- Start of radiation therapy possible within 2 weeks from AA-PET
- Karnofsky Performance Score (KPS) ≥ 70%
- Age ≥ 18 years
- Written informed consent (IC) obtained
Exclusion Criteria:
- - 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
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS)
Outcome Time Frame:
6 months after randomization
Safety Issue:
No
Principal Investigator
Anca-Ligia Grosu, Prof. Dr. med.
Investigator Role:
Study Chair
Investigator Affiliation:
Department of Radiotherapy, University Hospital Freiburg
Authority:
Germany: Ethics Commission
Study ID:
AG NUK/RT 2010-1
NCT ID:
NCT01252459
Start Date:
July 2011
Completion Date:
July 2014
Related Keywords:
- Recurrent Glioma (Glioblastoma Multiforme)
- AA-PET
- T1-Gd-MRI
- re-irradiation
- recurrent glioma
- Glioblastoma
- Glioma
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