Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases

NCT00950001 | Active Not Recruiting Phase 3

• 3 other identifiers: 2009-0381NCI-2011-00542P30CA016672
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Malignant Neoplasm in the Brain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall survival

  Up to 8 years

• Development of distant brain metastases

  Up to 8 years

• Incidence of complications related to treatment

  Up to 8 years

• Proportion of patients experiencing neurological complications

  Up to 8 years

• Proportion of complications resulting in prolongation of hospital stay

  Up to 8 years

Study Arms (2)

Arm I (SRS)

EXPERIMENTAL

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

Radiation: Stereotactic Radiosurgery

Arm II (observation)

NO INTERVENTION

Patients undergo clinical observation after craniotomy.

Interventions

Stereotactic Radiosurgery RADIATION

Undergo SRS

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Arm I (SRS)

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 28687375 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Debra NAna Yeboa

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: July 31, 2009
• Study Start: August 13, 2009
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)