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New radiation dosing strategy aims to tame large brain metastases

NCT ID NCT01705548

Disease control Sponsor: Emory University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase I trial tested a special type of radiation called hypofractionated radiosurgery for people with large brain metastases (tumors that spread from other cancers). The goal was to find the safest and most effective dose while limiting damage to healthy brain tissue. Twenty-four adults with solid tumors and one large brain metastasis (at least 3 cm) received radiation in 5 sessions over 1-2 weeks. Researchers monitored side effects and tumor control to determine the best dose for future studies.

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 (radiation therapy)
What this could lead to
If successful, this could establish a safer, more effective radiation dose for treating large brain metastases, potentially improving local tumor control while reducing side effects.
What could go wrong
This is a small, early-phase trial focused on safety and dosing, not efficacy. The approach may still cause brain tissue damage (radiation necrosis) or fail to control the tumor long-term.

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

24 people

The number who actually took part.

Started

Sep 2012

Finished

Sep 2023

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: * Pathologic proven diagnosis of solid tumor malignancy * One brain metastasis or brain metastasis resection cavity with maximal diameter ≥ 3 cm (or ≥ 14 cc.) and ≤ 6 cm (or ≤ 113 cc.) * Recursive partitioning analysis (RPA) class I-II/ Karnofsky Performance status (KPS) ≥ 70% Exclusion Criteria: * Prior stereotactic radiosurgery (SRS) to adjacent lesion such that planning target volume would have received more than 12 Gy * RPA class III (KPS \< 70%) * Brain metastasis or resection cavity volume \< 3 cm or \> 6 cm * Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies * Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation) * Evidence of leptomeningeal disease by magnetic resonance imaging (MRI) and/or cerebrospinal fluid (CSF) cytology * Current pregnancy * More than 8 weeks between resection and radiosurgical procedure * Metastases to brain stem, midbrain, pons, or medulla or within 5 mm of the optic apparatus (optic nerves and chiasm) * Inability to undergo MRI evaluation for treatment planning and follow-up

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Conditions

The condition(s) this trial relates to.

brain cancer cancer metastatic malignant neoplasm in the brain

As listed by the trial registrant

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

Metastatic malignant neoplasm to brain Unspecified adult solid tumor, protocol specific

Contacts and locations

Locations

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

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