Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
NCT ID:
NCT01795300
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01795300
Study Brief:
Protocol Section:
NCT01795300