Multisession Radiosurgery in Residual/Recurrent Grade II Meningiomas.
ATM
Hypofractionated Stereotactic Radiotherapy (Multisession Radiosurgery) in Residual/Recurrent Grade II Meningiomas: Feasibility Study.
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2019
CompletedFirst Submitted
Initial submission to the registry
September 14, 2021
CompletedFirst Posted
Study publicly available on registry
October 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedOctober 18, 2021
October 1, 2021
2 years
September 14, 2021
October 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
through study completion, up to 2 year
Secondary Outcomes (1)
Local control
through study completion, up to 2 year
Study Arms (1)
Multisession radiosurgery
EXPERIMENTALRadiosurgery
Interventions
Multisession radiosurgery (hypofractionated radiotherapy) with Cyberknife
Eligibility Criteria
You may qualify if:
- Patients had residual or recurrent atypical meningioma (grade II) after surgery (Simpson score)
- Age: ≥ 18 years old
- Karnofsky performance Status ( KPS) ≥ 70
- Written consent
You may not qualify if:
- Pregnancy
- Neurofibromatosis type 2 (NF2)
- Concomitant aggressive haematological or solid neoplasm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UOC Radioterapia
Milan, 20133, Italy
Related Publications (3)
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.
PMID: 25304271BACKGROUNDAghi 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.
PMID: 19145156BACKGROUNDMarchetti 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.
PMID: 35378640DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2021
First Posted
October 18, 2021
Study Start
May 17, 2017
Primary Completion
May 7, 2019
Study Completion
May 1, 2023
Last Updated
October 18, 2021
Record last verified: 2021-10