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Brain cancer breakthrough? new radiation after surgery may stop tumors

NCT ID NCT00950001

Disease control Sponsor: M.D. Anderson Cancer Center 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This study tests whether a precise type of radiation called stereotactic radiosurgery, given after surgery to remove brain tumors, can prevent the tumors from coming back. About 132 patients with up to 3 brain metastases will be randomly assigned to receive either the radiation or just observation. The goal is to see if the radiation improves local control and overall survival without causing more side effects.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 132 people

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

Started

Aug 2009

Expected to finish

Apr 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

4 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: 1. Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3). 2. Patients must have 3 or fewer newly diagnosed metastatic lesions in the brain with a complete resection of at least one lesion as determined the study neuroradiologist. 3. The resection cavity must have a maximum diameter of less than or equal to 4cm. This criteria will be determined by the study radiologist. 4. Additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm. 5. Patients must be considered candidates for SRS within 30 days of surgical resection. 6. Patients must have a Karnofsky Performance Scores (KPS) of at least 70 at the first post operative visit. Patients under 18 years of age must have a Lansky Performance Score of of at least 70. 7. Patients must be able to undergo an MRI scan. 8. Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form. Exclusion Criteria: 1. Patients who have received prior radiation therapy to the brain for any reason. 2. There is radiographic evidence of leptomeningeal disease prior to study entry. 3. The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma. 4. For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy).

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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.

Metastatic malignant neoplasm in the brain

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.