DRKS00015160
Recruiting
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 sites80 target enrollmentJuly 27, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- C71
- Sponsor
- Abteilung Klinische Neuroonkologie, Klinik für Neurologie, Universitätsklinikum Essen
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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