Status:
UNKNOWN
Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme
Lead Sponsor:
University Hospital Freiburg
Collaborating Sponsors:
Clinical Trials Center Freiburg
University of Freiburg
Conditions:
Recurrent Glioma (Glioblastoma Multiforme)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01252459
Start Date
July 1 2011
End Date
July 1 2014
Last Update
December 16 2010
Active Locations (1)
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1
Department of Radiotherapy, University Hospital Freiburg
Freiburg I. Br., Baden-Wurttemberg, Germany, 79106