Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme - a Randomised Phase II Trial
- Conditions
- C71Malignant neoplasm of brain
- Registration Number
- DRKS00000634
- Lead Sponsor
- niversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
1. Patient's written informed consent (IC) obtained latest the day after FET-PET acquisition
2. Legal capacity: Patient is able to understand the nature, significance and consequences of the study
3. Age > 18 years (no upper limit of age)
4. Karnofsky Performance Score (KPS) > 60%
5. Registration performed
6. Recurrence of a Glioblastoma multiforme (GBM) (WHO grade IV) and either not eligible for tumor resection or with macroscopic residual tumor after resection of the recurrent GBM
7. Histological confirmation of a Glioblastoma multiforme (GBM) at initial or secondary diagnosis
8. Previous radiation therapy of high grade glioma (WHO III or WHO IV) with a total dose of maximum 59-60 Gy (single dose 1.8 - 2.0 Gy)
9. At least 6 months between the end of pre-irradiation and randomisation
10. Recurrent tumor visible on FET-PET and MRI-T1(Gd) with the maximum diameter measuring 1 cm to 6 cm by either technique. If multifocal tumor, the sum of all diameters has to be 1-6 cm on FET-PET and T1(Gd)-MRI
11. Target volume definition possible according to both study arms
12. Start of re-irradiation planned within 2 weeks from FET-PET and MRI
1. Patient is not able to understand the nature, significance and consequences of the study
2. Patient's written informed consent has been obtained later than the day after the FET-PET acquisition
3. No histological confirmation of GBM
4. Recent (= 4 weeks before IC) histological result showing no tumor recurrence
5. No prior radiation treatment of high grade glioma HGG (WHO III or WHO IV)
6. Previous treatment of GBM with Avastin or other molecular targeted therapies less than 6 months before MRI and FET-PET used for radiotherapy planning
7. Technical impossibility to use MRI or FET-PET dataset for RT planning
8. Less than 2 weeks between the last day of last chemotherapy given, if other than TMZ or CCNU, and planned start of re-irradiation
9. Less than 3 weeks between resection of recurrent GBM and planned start of re-irradiation
10. Molecular targeted therapies or chemotherapy other than TMZ or CCNU planned during re-irradiation
11. Additional molecular targeted therapy or chemotherapy other than TMZ or CCNU or further surgery planned before diagnosis of further tumor progression after study intervention
12. Simultaneous participation in other interventional trials which could interfere with this trial and/or participation in a clinical trial within the last thirty days before the start of this study and/or previous participation (randomisation) in this study
13. Pregnancy, nursing, or patient not willing to prevent a pregnancy during treatment
14. Known or persistent abuse of medication, drugs or alcohol
15. Known allergy against the MRI contrast agent Gadolinium or the PET tracer 18F-FET or against any of the components
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) (Time Frame: 6 months after randomization)
- Secondary Outcome Measures
Name Time Method