Status:
ACTIVE_NOT_RECRUITING
Carbon Ion Radiotherapy for Atypical Meningiomas
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Meningioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50 and 70%, depending on resection status. A series ...
Eligibility Criteria
Inclusion
- histologically confirmed atypical meningioma
- macroscopic tumor after biopsy or subtotal resection
- Simpson Grade 4 or 5
- prior photon radiotherapy to the clinical target volume (CTV) of 48-52 Gy
- beginning of study treatment no later than 12 weeks after surgery
- age ≥ 18 years of age
- Karnofsky Performance Score ≥ 60
- For women with childbearing potential, 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
- refusal of the patients to take part in the study
- previous radiotherapy of the brain
- optic nerve sheath meningioma (ONSM)
- time interval of \> 12 weeks after primary diagnosis (neurosurgical intervention) and beginning of study treatment
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01166321
Start Date
June 1 2012
End Date
February 1 2026
Last Update
January 5 2024
Active Locations (1)
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1
University Hopsital Heidelberg
Heidelberg, Germany, 69120