Multisession Radiosurgery in Residual/Recurrent Grade II Meningiomas. (ATM)

Hypofractionated Stereotactic Radiotherapy (Multisession Radiosurgery) in Residual/Recurrent Grade II Meningiomas: Feasibility Study.

Fractionated radiosurgery will be delivered to atypical meningioma lesions in salvage setting for patients who present post-surgical residual lesion or develop recurrence.

Study Overview

• Status: Recruiting
• Conditions: Meningioma Atypical
• Intervention / Treatment: Procedure: Radiosurgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renato Mantegazza, MD; Phone Number: 2321 +39022394; Email: crc@istituto-besta.it

Study Locations

• Italy
  • Milano, Italy, 20133
    • Recruiting
    • UOC Radioterapia
    • Principal Investigator: Laura Fariselli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multisession radiosurgery; Radiosurgery	Procedure: Radiosurgery; Multisession radiosurgery (hypofractionated radiotherapy) with Cyberknife

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, up to 2 year

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): May 7, 2019
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: radiosurgery; atypical meningioma; multisession radiosurgery; recurrence meningioma
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Meningioma
• Other Study ID Numbers: ATM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No