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Can more radiation sessions tame large brain tumors safely?

NCT ID NCT03412812

Disease control Sponsor: University of Alabama at Birmingham 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving higher doses of radiation over five sessions is safe for people with brain metastases that are 2 to 6 cm in size. These larger tumors are often too risky for a single high-dose treatment. The trial enrolled 13 adults and aimed to find the highest dose that does not cause severe side effects.

What this could mean

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

Active substance
radiation therapy
What this could lead to
If successful, this could establish a safer, more effective radiation dose for treating larger brain tumors that are not good candidates for single-session radiosurgery.
What could go wrong
This is a very early, small (13 participants) dose-finding study, not a large efficacy trial. The results may not apply to all patients, and there is a risk of radiation-related brain swelling or other toxicity.

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

13 people

The number who actually took part.

Started

Jul 2018

Finished

Oct 2025

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: * All patients must have histologically confirmed malignancy. * All patients must have imaging suggestive of one or more brain metastases. * Karnofsky performance status (KPS) ≥ 60 * Age \> 18 years * Patients must provide written informed consent to participate in the study. * Patients must have less than or equal to 10 brain metastases as identified on brain MRI. Exclusion Criteria: * History of surgical resection to the tumor of interest * History of radiation to the tumor of interest * History of previous whole brain irradiation * Receipt of systemic therapy within one week of planned radiation treatment except for hormonal agents. * Patient is unable to have MRI or MRI contrast. * Inability to meet the appropriate normal tissue dose constraints secondary to tumor location should result in exclusion of the patient / tumor. * Patients with a non-index tumor (second tumor) greater than 3 cm in diameter will be excluded.

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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

Contacts and locations

Locations

  • Hazelrig-Salter Radiation Oncology Center

    Birmingham, Alabama, 35233, United States

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