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Timing of brain radiation could change outcomes for cancer patients

NCT ID NCT05545007

Disease control Sponsor: Istituto Clinico Humanitas Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving focused radiation before surgery for large brain metastases works better than giving it after surgery. About 146 adults with solid tumors and one large brain metastasis will be randomly assigned to one of the two timing schedules. The main goal is to see if preoperative radiation reduces the chance of cancer spreading in the lining of the brain.

What this could mean

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

Active substance
Hypofractionated Radiosurgery (HSRS)
What this could lead to
If this trial succeeds, it could establish a better timing for radiation to reduce the spread of cancer cells in the brain lining and improve local control.
What could go wrong
This is a mid-stage trial with only 146 participants, so results may not apply to all patients. Radiation before surgery may carry unknown risks like impaired wound healing.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 146 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

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.

Ages

18 years and older

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: * Age \>18 years * Histological or cytological or radiological confirmation of solid tumor malignancy * Clinical indication for surgical resection of one brain metastasis * Karnosky performance status (KPS) ≥70 * Controlled or responsive extra cranial metastatic lesions * Limited brain metastases (1-4 BMs) * Single metastatic lesion ≥ 2.1 cm in maximum diameter (4 cm3) * Lesions ≤2 cm conditioning mass effect or neurological deficits or massive edema unresponsive to steroids * Written informed consent form Exclusion Criteria: * Prior WBRT * KPS \< 70 * Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease * Pregnant women * Prior open neurosurgery for malignancy * More than 4 brain metastases * Patients with incompatibility to perform MRI

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Conditions

The condition(s) this trial relates to.

brain cancer metastatic malignant neoplasm in the brain

As listed by the trial registrant

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

Brain metastases, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Sant'Andrea

    RECRUITING

    Rome, Rome, 00189, Italy

  • AOUC Azienda Ospedaliero-Universitaria Careggi

    RECRUITING

    Florence, Florence, 50134, Italy

  • ASST Spedali Civili di Brescia

    RECRUITING

    Brescia, Brescia, 25123, Italy

  • Azienda Ospedaliera Santa Maria di Terni

    RECRUITING

    Terni, Terni, 05100, Italy

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli

    RECRUITING

    Rome, Rome, 00168, Italy

  • IRCCS Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Ospedale del Mare

    RECRUITING

    Naples, Naples, 80147, Italy

  • Policlinico Umberto I

    ACTIVE_NOT_RECRUITING

    Rome, Rome, 00161, Italy

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