DRKS00015160招募中未知
Randomized trial of radiotherapy with protons vs. radiotherapy with photons for patients with WHO grade II-III glioma - GliProPh
Abteilung Klinische Neuroonkologie, Klinik für Neurologie, Universitätsklinikum Essen0 个研究点目标入组 80 人开始时间: 2018年7月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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. Histologically confirmed IDH-mutated WHO grade 2 or 3 glioma with
- •Indication for the implementation of radiotherapy according to the decision of the
- •local neuro-oncological conference of the study center.
- •2. Classification of the tumor according to the WHO classification 2021 incl. presence of the following markers:
- •- IDH1/2 mutation
- •- ATRX and/or 1p19q codeletion status.
- •- CDKN2A/B codeletion status
- •3. Karnofsky index of = 70%.
- •4. Patients must be = 18 years of age
- •5. Ihe initiation of radiotherapy must start for patients with CNS WHO grade 2 IDH-mutated gliomas within 7 weeks of surgery. In individual cases, initiation may be later, but no later than 10 weeks after surgery.
- •6. In patients with CNS WHO grade 2 IDH-mutated gliomas applies:
- •> There is an indication for radiotherapy (partial tumor resection, age > 40 years, relevant neurological deficit)
- •> Study inclusion at the time of tumor progression is possible, even
- •possible, even without temporal relation to the initial surgery, if the following criteria are fulfilled:
- •- No initial indication to perform radiotherapy
- •- At the time of tumor progression, there is an indication for radiotherapy according to the local tumor board
- •- At the time of recurrence, there is no need for a new operation to confirm the diagnosis if there is no imaging evidence of malignancy (see exclusion criterion no. 4)
- •-Radiation therapy must be given within 7 weeks of MRI (or surgery, if a new surgery has been performed). In individual cases, initiation may be later occur, but no later than 10 weeks after recurrence-MRI/surgery
- •7. Radiotherapy must bestart within 7 weeks after surgery for patients with CNS WHO grade 3 IDH-mutated gliomas In individual cases, radiotherapy may sart later, but no later than 10 weeks after surgery.
- •8. At the time of study inclusion, the interval to the last surgery should be = 2 weeks. Patients must have recovered from the effects of surgery
- •9. Patients must consent and be able to complete a neurocognitive
- •Baseline testing even before the first dose of radiation is administered.
- •10. Patient must give written consent to participate in the study prior to study enrollment
- •11. Patient is able to understand the purpose and scope of the study
- •and is willing to comply with the protocol and attend to the scheduled study visits.
- •12. Patients of childbearing potential must have a negative pregnancy test
- •(serum or urine), not older than 7 days, at the time of the first study intervention.
- •13. Laboratory values not older than 3 weeks prior to study enrollment:
- •- Absolute neutrophil granulocyte count = 1500/mm³
- •- Platelet count = 100 000/mm³
- •- Hemoglobin value (Hb) >10 g/dL
- •- Total bilirubin value = 1.5 times the upper range limit
- •- Values for aspartate aminotransferase (AST) and alanine-
- •aminotransferase (ALT) = 3 times the upper range limit
- •- Creatinine value = 1.5 times the upper range limit
排除标准
- •General exclusion criteria:
- •1. concurrent participation in another clinical interventional
- •study or participation in a clinical study that requires the administration of an investigational drug within 30 days prior to study inclusion.
- •2. physical or mental condition of the patient that, at the discretion of the
- •study physician, could place the patient at risk, could confound the study results, or could study results, or that could adversely affect the patient's participation in the clinical Study could adversely affect the patient's participation.
- •3. known or persistent abuse of drugs, alcohol, or medications.
- •Indication-specific exclusion criteria:
- •4. aA the time of tumor recurrence in patients with CNS WHO grade 2.
- •IDH-mutated gliomas there is MR morphological evidence of malignancy (e.g., marked KM enhancement indicative of grades 3-4).
- •5. Previous radiotherapy to the head or facial-neck region
- •6. Prior chemotherapy due to CNS neoplasia
- •7. Severe comorbidities that limit compliance with study requirements
- •8. Malignant invasive tumor disease with tumor freedom of < 3 years
- •9. Evidence of leptomeningeal dissimilarity
- •10. Spinal or infratentorial tumor location
- •11. Patients with known human immunodeficiency virus (HIV) infection
- •12. Patients with newly diagnosed hepatitis infection or, at the discretion of the responsible study physician - significant risk of reactivation
研究者
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