Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas (NCT02978677) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
90 participantsStarted 2022-10
Plain-language summary
The trial evaluates the effect of a moderately increased radiation dose in patients with atypical (grade II) and anaplastic (grade III) meningioma after incomplete or no surgery. Endpoint is recurrence-free survival after 5 years.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* histologically confirmed atypical (WHO grade II) or anaplastic (WHO grade III) meningioma with the indication for radiotherapy
* MRI (within 24h post-operative, if not available than with a time interval of \~ 6 weeks) including contrast-enhanced T1 weighted 3D dataset and PET for evaluation of macroscopic tumour (residuum)
* Karnofsky Performance Score ≥ 60, ECOG ≤2
* For women with childbearing potential, (and men) adequate contraception.
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent (must be available before enrolment in the trial)
Exclusion Criteria:
* refusal of the patients to take part in the study
* previous radiotherapy of the brain
* several manifestations of the meningioma in different regions of the brain or additional spinal manifestations
* distant metastases
* patients who are not suitable for radiotherapy
* known other malignant disease within 5 years before radiotherapy (except tumours that likely do not impact prognosis and likely not require treatment interfering with study therapy, e.g. in-situ carcinoma of the breast or cervix uteri)
* pregnant or lactating women
* patients with non-MRI compatible metal implants, pacemaker or non-MRI compatible external automatic defibrillators
* patients not able to understand character and individual consequences of the clinical trial
* claustrophobic patients
* current participation in another clinical intervention stud…