An interventional study of Carbon Ion Radiotherapy in Meningioma, sponsored by University Hospital Heidelberg. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Treatment
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 or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.
Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.
First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.
Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection or biopsy.
Primary endpoint is progression-free survival rate, secondary endpoints are overall survival, safety and toxicity.
226 studies on the registry are indexed under Meningioma; 87 are open to participants now.
This study's enrollment of 35 is below the median of 40 across 161 interventional studies indexed under Meningioma.
Browse Meningioma studies →University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Carbon Ion Boost to the Macroscopic Tumor visible on contrast-enhanced MR-Imaging
Radiation: Carbon Ion Radiotherapy
Carbon Ion Boost 18 Gy E in single Fractions of 3 Gy E
Progression-free survival
Time frame: Progression-free survival at 3 years
Overall Survival
Time frame: Overall Survival at 3 years
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University Hospital Heidelberg