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NCT Number: NCT00950001

Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Malignant Neoplasm in the Brain Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVES:

I. To evaluate benefit of post-surgical stereotactic radiosurgery (SRS) on the resection bed in providing 6 month local control (decreasing the risk of local tumor recurrence) when compared to surgical resection alone.

SECONDARY OBJECTIVES:

I. Overall survival, development of distant brain metastases and complications related to treatment.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy.

ARM II: Patients undergo clinical observation after craniotomy.

After completion of study treatment, patients are followed up at 5-8 weeks, every 6-9 weeks for 1 year, every 3-4 months for 1 year, and then every 6 months thereafter.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients who have received prior radiation therapy to the brain for any reason.
  • There is radiographic evidence of leptomeningeal disease prior to study entry.
  • The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.
  • For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy).

Treatment and study plan

Stereotactic Radiosurgery

Radiation

Undergo SRS

Other names: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Primary outcomes

  1. Time to local recurrence

    Time frame: 6 months

    A univariate test between groups will be conducted using a log rank test of Kaplan-Meier survival estimates and multivariate analyses will be conducted via the Cox proportional hazards model. The hazard ratio comparing each arm will be computed for each endpoint with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the hazard ratio estimates. The proportion of patients experiencing neurological complications will be computed via univariate and multivariate logistic regression analysis.

Secondary outcomes

  1. Overall survival

    Time frame: Up to 8 years

    A univariate test between groups will be conducted using a log rank test of Kaplan-Meier survival estimates and multivariate analyses will be conducted via the Cox proportional hazards model. The hazard ratio comparing each arm will be computed for each endpoint with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the hazard ratio estimates.

  2. Development of distant brain metastases

    Time frame: Up to 8 years

    A univariate test between groups will be conducted using a log rank test of Kaplan-Meier survival estimates and multivariate analyses will be conducted via the Cox proportional hazards model. The hazard ratio comparing each arm will be computed for each endpoint with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the hazard ratio estimates.

  3. Incidence of complications related to treatment

    Time frame: Up to 8 years

    The proportions of patients experiencing neurological complications will be computed via univariate and multivariate logistic regression analysis. The proportion of complications resulting in prolongation of hospital stay will also be computed. The odds ratios comparing both arms will be computed with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the odds ratio estimates.

  4. Proportion of patients experiencing neurological complications

    Time frame: Up to 8 years

    Computed via univariate and multivariate logistic regression analysis.

  5. Proportion of complications resulting in prolongation of hospital stay

    Time frame: Up to 8 years

    Will be computed.

  6. Time to first neurological complication

    Time frame: Up to 8 years

    A univariate test between groups will be conducted using a log rank test of Kaplan-Meier survival estimates and multivariate analyses will be conducted via the Cox proportional hazards model. The hazard ratio comparing each arm will be computed for each endpoint with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the hazard ratio estimates.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial

Important dates

Study start
2009
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2009
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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