NCT00950001Active, not recruitingPhase 3
Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases
Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
This randomized phase III trial studies stereotactic radiosurgery to see how well it works compared to clinical observation after surgery in treating patients with brain metastases. Stereotactic radiosurgery, a type of radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 30 Jul 2009
- Start date
- 13 Aug 2009
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Childhood cancers
- NCT number
- NCT00950001
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 132
- From 13 Aug 2009 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received prior radiation therapy to the brain for any reason.
- There is radiographic evidence of leptomeningeal disease prior to study entry.
Other illness
- The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.
Other
- For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy).
Who the study is looking for
- Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3).
- 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.
- The resection cavity must have a maximum diameter of less than or equal to 4cm. This criteria will be determined by the study radiologist.
- Additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm.
- Patients must be considered candidates for SRS within 30 days of surgical resection.
- 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.
- Patients must be able to undergo an MRI scan.
- Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form.
Age in the registry: 4 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.