Multisession Radiosurgery in Residual/Recurrent Grade II Meningiomas. (ATM)
Primary Purpose
Meningioma Atypical
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Radiosurgery
Sponsored by
About this trial
This is an interventional other trial for Meningioma Atypical focused on measuring atypical meningioma, radiosurgery, multisession radiosurgery, recurrence meningioma
Eligibility Criteria
Inclusion Criteria:
- Patients had residual or recurrent atypical meningioma (grade II) after surgery (Simpson score)
- Age: ≥ 18 years old
- Karnofsky performance Status ( KPS) ≥ 70
- Written consent
Exclusion Criteria:
- Pregnancy
- Neurofibromatosis type 2 (NF2)
- Concomitant aggressive haematological or solid neoplasm
Sites / Locations
- UOC RadioterapiaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multisession radiosurgery
Arm Description
Radiosurgery
Outcomes
Primary Outcome Measures
Neurological side effects
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).
Secondary Outcome Measures
Local control
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
Full Information
NCT ID
NCT05081908
First Posted
September 14, 2021
Last Updated
October 5, 2021
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
1. Study Identification
Unique Protocol Identification Number
NCT05081908
Brief Title
Multisession Radiosurgery in Residual/Recurrent Grade II Meningiomas.
Acronym
ATM
Official Title
Hypofractionated Stereotactic Radiotherapy (Multisession Radiosurgery) in Residual/Recurrent Grade II Meningiomas: Feasibility Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
May 7, 2019 (Actual)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fractionated radiosurgery will be delivered to atypical meningioma lesions in salvage setting for patients who present post-surgical residual lesion or develop recurrence.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningioma Atypical
Keywords
atypical meningioma, radiosurgery, multisession radiosurgery, recurrence meningioma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multisession radiosurgery
Arm Type
Experimental
Arm Description
Radiosurgery
Intervention Type
Procedure
Intervention Name(s)
Radiosurgery
Intervention Description
Multisession radiosurgery (hypofractionated radiotherapy) with Cyberknife
Primary Outcome Measure Information:
Title
Neurological side effects
Description
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
Secondary Outcome Measure Information:
Title
Local control
Description
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
Time Frame
through study completion, up to 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients had residual or recurrent atypical meningioma (grade II) after surgery (Simpson score)
Age: ≥ 18 years old
Karnofsky performance Status ( KPS) ≥ 70
Written consent
Exclusion Criteria:
Pregnancy
Neurofibromatosis type 2 (NF2)
Concomitant aggressive haematological or solid neoplasm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renato Mantegazza, MD
Phone
+39022394
Ext
2321
Email
crc@istituto-besta.it
Facility Information:
Facility Name
UOC Radioterapia
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Fariselli, MD
Email
laura.fariselli@istituto-besta.it
First Name & Middle Initial & Last Name & Degree
Laura Fariselli, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25304271
Citation
Ostrom QT, Gittleman H, Liao P, Rouse C, Chen Y, Dowling J, Wolinsky Y, Kruchko C, Barnholtz-Sloan J. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2007-2011. Neuro Oncol. 2014 Oct;16 Suppl 4(Suppl 4):iv1-63. doi: 10.1093/neuonc/nou223. No abstract available.
Results Reference
background
PubMed Identifier
19145156
Citation
Aghi MK, Carter BS, Cosgrove GR, Ojemann RG, Amin-Hanjani S, Martuza RL, Curry WT Jr, Barker FG 2nd. Long-term recurrence rates of atypical meningiomas after gross total resection with or without postoperative adjuvant radiation. Neurosurgery. 2009 Jan;64(1):56-60; discussion 60. doi: 10.1227/01.NEU.0000330399.55586.63.
Results Reference
background
PubMed Identifier
35378640
Citation
Marchetti M, Pinzi V, Iezzoni C, Morlino S, Tramacere I, De Martin E, Cane I, Fariselli L. Multisession radiosurgery for grade 2 (WHO), high risk meningiomas. A phase II clinical trial. J Neurooncol. 2022 May;157(3):397-403. doi: 10.1007/s11060-022-03978-w. Epub 2022 Apr 4.
Results Reference
derived
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Multisession Radiosurgery in Residual/Recurrent Grade II Meningiomas.
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