C71
Conditions
Interventions
Group 1: All patients will recieve the same radiotherapy independent of participation in the study.
Target volume delineation will be based on AA-PET and T1-Gd-MRI: GTV = AA uptake on PET respectivel
Sponsors
Klinik für Strahlenheilkunde
Universitätsklinik Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relevant AA-PET/MRI non-overlap (yes/no), defined as non-overlapping tumor volume of AA-PET and MRI = 2ml. 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS), Overall Survival (OS), topography of recurrence, localization of necrosis after re-irradiation, comparison of acute and late toxicity. Impact of diffusion/perfusion MRI on target volume delineation. | — |
Countries
Germany
Contacts
Public ContactTanja Schimek-Jasch
Klinik für Strahlenheilkunde Universitätsklinik Freiburg
Outcome results
None listed