Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme (GLIAA)
Recruitment status was Not yet recruiting
Recurrent Glioma (Glioblastoma Multiforme)
Radiation: Radiation Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme - a Randomised Phase II Trial|
- Progression Free Survival (PFS) [ Time Frame: 6 months after randomization ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1 year after randomisation ] [ Designated as safety issue: No ]Kaplan-Meier: Performed on the per protocol population - all patients who are eligible and have started their allocated treatment
- Volumetrical assessment of GTV and PTV [ Time Frame: Interim analysis ] [ Designated as safety issue: No ]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.
- Topography of recurrence [ Time Frame: Follow up (end of radiotherapy, 6 and 12 weeks after radiotherapy, then every 3 months) ] [ Designated as safety issue: No ]local relationship between recurrence and AA-PEt and MRI-derived TV
- Localisation of necrosis after re-irradiation [ Time Frame: Follow up (end of radiotherapy, 6 and 12 weeks after radiotherapy, then every 3 months) ] [ Designated as safety issue: Yes ]
- Rate of long-term survivors [ Time Frame: Follow up ] [ Designated as safety issue: No ]Rate of long-term survivors = Survivors > 1 year after randomisation
- Quality of Life (QoL) [ Time Frame: During Radiotherapy and Follow Up ] [ Designated as safety issue: No ]QoL assessed by the EORTC QlQ-C 15 PAL questionnaire
- Rate of side effects [ Time Frame: During Radiotherapy and Follow Up ] [ Designated as safety issue: Yes ]Assessed according to CTCAE
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm A: AA-PET based target volume delineation
Experimental intervention (Arm A): High-precision re-irradiation. Target volume delineation based on AA-PET.
Radiation: Radiation Therapy
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
Active Comparator: Arm B: T1Gd-MRI based target volume delineation
Control intervention (Arm B): High-precision re-irradiation. Target volume delineation based on T1Gd-MRI.
Radiation: Radiation Therapy
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252459
|Contact: Anca-Ligia Grosu, Prof. Dr. med.||0049-761-270 ext firstname.lastname@example.org|
|Contact: Ursula Nestle, PD Dr. med.||0049-761-270 ext email@example.com|
|Department of Radiotherapy, University Hospital Freiburg||Not yet recruiting|
|Freiburg i. Br., Baden-Wuerttemberg, Germany, 79106|
|Sub-Investigator: Nicole Wiedenmann, Dr. med.|
|Sub-Investigator: Marianne Schmucker, Dr. med.|
|Sub-Investigator: Tanja Schimek-Jasch|
|Principal Investigator: Anca-Ligia Grosu, Prof. Dr. med.|
|Principal Investigator: Wolfgang Weber, Prof. Dr. med.|
|Study Chair:||Anca-Ligia Grosu, Prof. Dr. med.||Department of Radiotherapy, University Hospital Freiburg|
|Study Chair:||Wolfgang Weber, Prof. Dr. med.||Department of Nuclear Medicine, University Hospital Freiburg|
|Study Chair:||Ursula Nestle, PD Dr. med.||Department of Radiotherapy, University Hospital Freiburg|