Status:
WITHDRAWN
Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Skull Base Meningioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In PINOCCHIO-Triayl, carbon ion radiotherapy is compared to proton and advanced photon radiotherapy in patients with skull base meningiomas. There will be two treatment arms with photons, one arm with...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01795300
Start Date
May 1 2020
End Date
May 1 2022
Last Update
October 6 2021
Active Locations (1)
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1
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120