Focused radiation doses put to the test for large brain tumors

NCT ID NCT03726359

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This trial investigates the safest and most effective dose of fractionated stereotactic radiation therapy (FSRT) for people with large brain metastases (tumors that have spread from other cancers). Participants receive radiation in several small doses over 1.5 to 2 weeks. The study aims to find the maximum dose that can be given without causing severe side effects, and to measure how well the tumors respond. Results will help design future larger studies.

What this could mean

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

Active substance
Fractionated Stereotactic Radiation Therapy (FSRT)
What this could lead to
If successful, this could establish a standard dosing regimen for FSRT in large brain metastases, improving tumor control while limiting side effects.
What could go wrong
This is an early-phase dose-finding study with only 30 participants, so results may not apply broadly. There is a risk of radiation-related toxicities, including brain swelling or necrosis.

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 43 people

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

Started

Dec 2017

Expected to finish

Jun 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: * Pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration * Intact (unresected) brain metastases measuring ≥3 cm and ≤ 6 cm in largest dimension on gadolinium contrast enhanced MRI obtained within 30 days prior to registration OR Surgically resected brain metastasis for which postoperative stereotactic radiotherapy is indicated, with expected target measuring ≥3 cm and ≤6 cm in largest dimension * Prior Whole Brain Radiation Therapy (WBRT) is allowed * Age ≥ 18 years * Women of childbearing potential and male participants must practice adequate contraception * History/Physical examination within 30 days prior to registration * Life expectancy \>3 months * Patients are allowed to enroll if previously treated to other lesions with Stereotactic Radiosurgery (SRS) * Patients with multiple lesions are allowed, as long there is one dominant lesion that will be treated with FSRT. Other lesions may be treated concurrently with SRS or FSRT at the discretion of the treating physician but will not contribute to the study endpoints Exclusion Criteria: * Patients with definitive leptomeningeal metastases, based on cerebrospinal fluid (CSF) examination * Plan for chemotherapy or targeted agents during treatment. Hormonal therapy, immunotherapy targeting PD-1/PD-L1 axis, and bone supportive therapy may be continued during treatment * Contraindication to enhanced MRI imaging such as implanted metal devices. However, patients with implanted devices which are MRI compatible are allowed * Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy * Uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, and uncontrolled seizure activity * Previous treatment of the target lesion with radiotherapy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

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