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Multisession Radiosurgery in Residual/Recurrent Grade II Meningiomas.

NCT ID: NCT05081908

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-17

Study Completion Date

2023-05-31

Brief Summary

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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

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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.

Conditions

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Meningioma Atypical

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Multisession radiosurgery

Radiosurgery

Group Type EXPERIMENTAL

Radiosurgery

Intervention Type PROCEDURE

Multisession radiosurgery (hypofractionated radiotherapy) with Cyberknife

Interventions

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Radiosurgery

Multisession radiosurgery (hypofractionated radiotherapy) with Cyberknife

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UOC Radioterapia

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Renato Mantegazza, MD

Role: CONTACT

[email protected]
+39022394 ext. 2321

Facility Contacts

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Laura Fariselli, MD

Role: primary

[email protected]

References

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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.

Reference Type BACKGROUND
PMID: 25304271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19145156 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35378640 (View on PubMed)

Other Identifiers

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ATM

Identifier Type: -

Identifier Source: org_study_id