DRKS00000634已完成2 期
Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme - a Randomised Phase II Trial - GLIAA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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