Wissen schafft Zukunft.

  Klinik und Poliklinik
  für RadioOnkologie
  und Strahlentherapie

  Klinikleitung
  Univ.-Prof. Dr. med.
  Stephanie E. Combs

  Klinikum rechts der Isar
  Technische Universität München
  Ismaninger Str. 22
  D - 81675 München
  direktion.radonk@mri.tum.de

 

GLIAA Studie

Amino-acid PET versus MRI guided re-irradiation in patients with recurrent glioblastoma multiforme - a randomised phase II trial

This study is designed to test if a radiotherapy target volume delineation based on Amino-acid PET (AA-PET) leads to an improvement in progression free survival in patients with recurrent GBM treated with re-irradiation, compared to target volume delineation based on Gadolinium contrast enhanced T1 weighted Magnetic Resonance Imaging (T1Gd-MRI).

 

Inclusion criteria

  • Local recurrence of GBM (WHO grade IV) and either not eligible for tumor resection or with macroscopic residual tumor after resection of recurrent GBM
  • Histological confirmation of GBM at initial or secondary diagnosis
  • Previous radiation therapy of the primary with a maximal total dose 59-60 Gy
  • At least 6 months since the end of pre-irradiation
  • Recurrent tumor visible on AA-PET and T1Gd-MRI with the diameter measuring 1cm to 6cm by either technique
  • Target volume definition possible according to both study arms
  • Start of re-irradiation possible within 2 weeks from FET-PET and MRI
  • Patient's written IC obtained on the day of FET-PET acquisition or latest the day after FET-PET acquisition
  • Legal capacity
  • Karnofsky Performance Score (KPS) > 60%
  • Age ≥18 years (no upper limit of age)
  • Registration

Exclusion criteria

  • No histological confirmation of GBM
  • Recent (≤4 weeks before IC) histological result showing no tumor recurrence
  • No prior radiation treatment to the primary tumor
  • More than 2 previous chemotherapy regimes or previous treatment with Avastin or other molecular targeted therapies
  • Technical impossibility to use MRI or FET-PET for Radiation Therapy (RT)-planning
  • Less than 2 weeks between application of chemotherapy and planned start of re-irradiation
  • Less than 3 weeks between resection of recurrent GBM and planned start of re-irradiation
  • Chemotherapy or molecular targeted therapies planned during re-irradiation
  • Additional chemotherapy or molecular targeted therapy or further surgery planned before diagnosis of further tumor progression after study intervention
  • Female patients of childbearing potential who are pregnant or breast feeding
  • Fertile patients refusing to use safe contraceptive methods during the study
  • Known allergy against the MRI contrast agent Gadolinium or the PET tracer 18F FET or against any of the components

Aktuelles


24.10.2018: Stellenangebot: Sekretärin in Vollzeit (38,5 Std./Woche). Mehr dazu: Stellenausschreibungen


10.10.2018: Stellenangebot: Kommen Sie zu uns und werden Sie Teil unseres erfolgreichen Teams als MTRA (w/m):
Stellenanzeige: MTRA Stelle

Mehr dazu: Stellenausschreibungen


24.08.2018: Wir stellen ein: Assistenzärztin/-arzt, MFA (m/w). Mehr dazu: Stellenausschreibungen


17.07.2018: Erster Patient an der NEUEN TOMOTHERAPIE (RADIXACT) bestrahlt.