GLIAA-Pilot: Amino-acid PET versus MRI guided tumor volume delineation followed by re-irradiation in patients with recurrent glioblastoma multiforme - A feasibility trial - GLIAA-Pilot

Klinik für StrahlenheilkundeUniversitätsklinik Freiburg0 个研究点目标入组 34 人开始时间: 2010年12月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

发起方

Klinik für StrahlenheilkundeUniversitätsklinik Freiburg