RecruitingPhase 3NCT03741673

Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases

A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS for Brain Metastases

Sponsor

M.D. Anderson Cancer Center

Enrollment

180 participants

Start Date

Nov 8, 2018

Study Type

INTERVENTIONAL

Conditions

Metastatic Malignant Neoplasm in the Brain Malignant Neoplasm

Summary

This phase III trial studies stereotactic radiosurgery (SRS) before surgery to see how well it works compared with SRS after surgery in treating patients with cancer that has spread to the brain (brain metastases). SRS is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

The primary lesion pre-operatively can have a maximum diameter of =< 4 cm for single fraction and =< 7 cm for multifraction therapy
Patients must be considered candidates for SRS within +/- 30 days of surgical resection as defined by either history and physical (H\&P) or presentation at brain metastasis tumor board conference note
Patients must have a Karnofsky performance scores >= 70 or Eastern Cooperative Oncology Group (ECOG) >= 2 within 30 days of enrollment
Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form
No radiographic evidence of leptomeningeal disease on MD Anderson Cancer Center (MDACC) departmental radiology report or study neuro-radiologist review
Documented history of malignancy

Exclusion Criteria3

Patients who have received prior radiation therapy to the brain for any reason
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)

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