Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Malignant Neoplasm in the Brain
• Intervention / Treatment: Radiation: Stereotactic Radiosurgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (SRS); Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy.	Radiation: Stereotactic Radiosurgery; Undergo SRS; Other Names: Stereotactic External Beam Irradiation; stereotactic external-beam radiation therapy; stereotactic radiation therapy; Stereotactic Radiotherapy; stereotaxic radiation therapy; stereotaxic radiosurgery
No Intervention: Arm II (observation); Patients undergo clinical observation after craniotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to local recurrence	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	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.	Up to 8 years
Development of distant brain metastases	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.	Up to 8 years
Incidence of complications related to treatment	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.	Up to 8 years
Proportion of patients experiencing neurological complications	Computed via univariate and multivariate logistic regression analysis.	Up to 8 years
Proportion of complications resulting in prolongation of hospital stay	Will be computed.	Up to 8 years
Time to first neurological complication	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.	Up to 8 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Debra NAna Yeboa, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Mahajan A, Ahmed S, McAleer MF, Weinberg JS, Li J, Brown P, Settle S, Prabhu SS, Lang FF, Levine N, McGovern S, Sulman E, McCutcheon IE, Azeem S, Cahill D, Tatsui C, Heimberger AB, Ferguson S, Ghia A, Demonte F, Raza S, Guha-Thakurta N, Yang J, Sawaya R, Hess KR, Rao G. Post-operative stereotactic radiosurgery versus observation for completely resected brain metastases: a single-centre, randomised, controlled, phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1040-1048. doi: 10.1016/S1470-2045(17)30414-X. Epub 2017 Jul 4.

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2009
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: July 30, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimated): July 31, 2009

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: 2009-0381 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2011-00542 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No