Randomized Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.
Inclusion Criteria
Inclusion Criteria
Patients meeting all of the following criteria will be considered for admission to the
trial:
- Histologically or imaging confirmed skull base meningioma
- macroscopic tumor - Simpson Grade 4 or 5
- age ≥ 18 years of age
- Karnofsky Performance Score >=60
- For women with childbearing potential, (and men) adequate contraception (sexual
abstinence, estrogen- or gestagen containing contraceptive medication etc.)
- Female participants: No pregnancy present (pregnancy test required)
- 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:
Patients presenting with any of the following criteria will not be included in the trial:
- refusal of the patients to take part in the study
- previous radiotherapy of the brain
- histologically confirmed atypical or anaplastic meningioma
- optic nerve sheath meningioma (ONSM)
- Patients who have not yet recovered from acute toxicities of prior therapies
- Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell
carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment
interfering with study therapy
- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials,
respectively.