GLIAA-Pilot: Amino-acid PET versus MRI guided tumor volume delineation followed by re-irradiation in patients with recurrent glioblastoma multiforme - A feasibility trial
- Conditions
- C71Malignant neoplasm of brain
- Registration Number
- DRKS00000633
- Lead Sponsor
- Klinik für StrahlenheilkundeUniversitätsklinik Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 34
Local recurrence of Glioma / 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 6 months since the end of pre-irradiation and start of re-irradiation
- At most 2 prior chemotherapy regimes
- Start of radiation therapy possible within 3 weeks from AA-PET
- Karnofsky Performance Score (KPS) >60%
- Age = 18 years
- Written informed consent (IC) obtained
- No histological confirmation of GBM
- 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 6 months between the end of first radiation treatment and start of re-irradiation
- 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 start of re-irradiation
- 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relevant AA-PET/MRI non-overlap (yes/no), defined as non-overlapping tumor volume of AA-PET and MRI = 2ml. <br>Let p denote the probability of relevant AA-PET/MRI non-overlap. The study is designed to test the null-hypothesis H0: p = 25% against the alternative hypothesis H1: p > 25% at significance level 5%. This will be done by an exact one-sided binomial test (analysis of the primary endpoint). <br>
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS), <br>Overall Survival (OS), topography of recurrence, <br>localization of necrosis after re-irradiation,<br>comparison of acute and late toxicity.<br>Impact of diffusion/perfusion MRI on target volume delineation. <br>