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Can multiple radiation doses tame large brain tumors?

NCT ID NCT02974127

Disease control Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial follows 178 adults with benign meningiomas that are large, medium-sized, or located near critical brain areas. Researchers use a robotic system called CyberKnife to deliver radiation in multiple sessions, aiming to control tumor growth while limiting damage to nearby healthy tissue. Over five years, they track side effects, tumor size on MRI scans, and neurological symptoms like facial pain or hearing issues. The study asks whether this precise, staged radiation approach can be a safe and effective option for tumors that are hard to treat with surgery or single-dose radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Multisession radiosurgery (CyberKnife) - a precise form of radiation therapy delivered in multiple sessions
What this could lead to
If it works, this approach could offer a non-invasive way to control large or tricky-to-reach meningiomas with fewer side effects than traditional surgery or single-dose radiation.
What could go wrong
This is an observational study, not a randomized trial, so it cannot prove the treatment is better than alternatives. Radiation can still cause side effects, and tumor control may not be permanent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

178 people

The number who actually took part.

Started

Aug 2011

Finished

Apr 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with large or in critical site benign intracranial meningioma diagnosis

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * either histologically confirmed or imaging-defined benign meningioma diagnosis; * large or medium lesion size and/or in critical area (e.i. perichiasmatic area); * signed specific informed consent; * age ≥ 18 years; * for female patients, execution of pregnancy blood test; * Karnofsky Performance Status (KPS) ≥ 70. Exclusion Criteria: * histologically confirmed diagnosis of atypical or malignant meningiomas; * patients who had received prior radiotherapy in the same site; * pregnancy; * allergy for contrast medium; * neurofibromatosis diagnosis.

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Conditions

The condition(s) this trial relates to.

intracranial meningioma meningioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial meningioma

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy

    Milan, 20133, Italy

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