UOC Radioterapia
Milan, Milano, 20133, Italy
NCT Number: NCT05081908
Fractionated radiosurgery will be delivered to atypical meningioma lesions in salvage setting for patients who present post-surgical residual lesion or develop recurrence.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Milan, Milano, 20133, Italy
Meningioma is the most common intracranial tumor (1). World Health Organization (WHO) grade II (atypical) meningioma recurs more frequently than WHO grade I (benign) meningioma, and patients with subtotally resected atypical meningioma should be treated with adjuvant radiation therapy (2). However, many atypical meningiomas can be gross totally resected, and whether to administer radiation to this population remains unclear. Apart from extent of resection, clinical characteristics such as age and gender and tumor-related characteristics such as tumor size and location have poor predictive capacity to determine which lesions will recur.
The lack of professional consensus on the role of adjuvant radiation therapy (RT) derived from the heterogeneity and retrospective nature of the published data: standard fractionation fails to demonstrate a benefit in term of local control and survival.
Recent advances in radiotherapy technology (staged radiosurgery) give the possibility to reach high dose levels only in tumor volume and in the same time to save the surrounding healthy tissues.
The purpose of this study is to verify the related toxicity of a new radiotherapy protocol and as second end point to evaluate the efficacy on disease local control at 3 years.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multisession radiosurgery (hypofractionated radiotherapy) with Cyberknife
Time frame: through study completion, up to 2 year
Frequency of neurological side effects related to the radiosurgical treatment, evaluated according with CTCAE scale at every follow-up (4 months post-treatment, then every 6 months).
Time frame: through study completion, up to 2 year
The rate of tumor response defined as follow on the basis of modification of MRI imaging evaluated also with advanced RM techniques:Partial response (PR) is defined as 20%, decrease in the volumetric size of the lesion on MRI; stable disease (SD) as no change in the size of the lesion; progressive disease (PD) increase in any volumetric size of the lesion, confirmed at least a the following two consecutive MR
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Other
Hypofractionated Stereotactic Radiotherapy (Multisession Radiosurgery) in Residual/Recurrent Grade II Meningiomas: Feasibility Study.
Acronym: ATM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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