Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases
- Conditions
- Malignant NeoplasmMetastatic Malignant Neoplasm in the Brain
- Registration Number
- NCT03741673
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria:<br><br> - The primary lesion pre-operatively can have a maximum diameter of =< 4 cm for single<br> fraction and =< 7 cm for multifraction therapy<br><br> - Patients must be considered candidates for SRS within +/- 30 days of surgical<br> resection as defined by either history and physical (H&P) or presentation at brain<br> metastasis tumor board conference note<br><br> - Patients must have a Karnofsky performance scores >= 70 or Eastern Cooperative<br> Oncology Group (ECOG) >= 2 within 30 days of enrollment<br><br> - Patients must agree to randomization as documented by signing the Institutional<br> Review Board (IRB) approved consent form<br><br> - No radiographic evidence of leptomeningeal disease on MD Anderson Cancer Center<br> (MDACC) departmental radiology report or study neuro-radiologist review<br><br> - Documented history of malignancy<br><br>Exclusion Criteria:<br><br> - Patients who have received prior radiation therapy to the brain for any reason<br><br> - The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma<br><br> - For females, if they are pregnant or breast-feeding (The exclusion is made because<br> gadolinium may be teratogenic in pregnancy)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Leptomeningeal disease (LMD)-free rate
- Secondary Outcome Measures
Name Time Method Local control rate;Distant brain control;Overall survival (OS)