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NCT03741673
Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases
Conditions: Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 180
Sponsor: M.D. Anderson Cancer Center
Location: M D Anderson Cancer Center Houston Texas
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 Criteria
Inclusion Criteria:
* 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 Criteria:
* 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)
Source: ClinicalTrials.gov (NCT03741673). StuddyBuddy aggregates publicly available trial information.