A Phase 3 interventional study of Quality-of-Life Assessment and Questionnaire Administration in Malignant Neoplasm and Metastatic Malignant Neoplasm in the Brain, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by M.D. Anderson Cancer Center · Phase 3, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
I. To investigate the 1 year leptomeningeal disease (LMD)-free rate among patients with surgically resectable metastatic brain lesions randomized to post-operative stereotactic radiosurgery (SRS) (standard care) versus pre-operative SRS followed by surgery (experimental arm).
SECONDARY OBJECTIVE:
I. To investigate the local control (LC), distant brain metastasis rate, overall survival (OS) of pre-operative (pre-op) versus (vs) post-operative (post-op) SRS in patients with brain metastasis.
EXPLORATORY OBJECTIVES:
I. To assess the reliability of different imaging features by using a combination of patient data and phantom data to quantify the uncertainties associated with using magnetic resonance imaging (MRI) for radiomics studies.
II. To assess the correlation of imaging-pathology correlates using multiparametric imaging that characterize the tumor and peri-tumoral microenvironment including features such as tumor vascular characteristics, cellular density, oxygenation and presence of inflammation/immune reactivity.
III. To investigate the neuro-cognitive impact, patient reported outcomes and health-related quality of life of pre-operative (pre-op) vs post-operative (post-op) SRS in patients with brain metastasis.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (PRE-OPERATIVE SRS): Patients undergo SRS within 15 days of randomization followed by surgery within 15 days. Patients may undergo additional SRS if disease returns after treatment.
GROUP II (POST-OPERATIVE SRS): Patients undergo surgery within 15 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment.
After completion of study treatment, patients are followed up periodically.
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Exclusion Criteria:
Patients undergo SRS within 30 days of randomization followed by surgery within 30 days. Patients may undergo additional SRS if disease returns after treatment.
Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Stereotactic Radiosurgery
Patients undergo surgery within 30 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment.
Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Stereotactic Radiosurgery
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Undergo SRS
Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery
Leptomeningeal disease (LMD)-free rate
Aalen-Johansen estimates will be used for LMD. Uni- and multi-variable analysis of time to LMD will be done using Fine-Gray proportional hazards regression. Model assumptions will be verified graphically by residual analyses.
Time frame: At 1 year
Local control rate
Aalen-Johansen estimates will be used for local recurrence. Uni- and multi-variable analysis of time to local recurrence will be done using Fine-Gray proportional hazards regression. Model assumptions will be verified graphically by residual analyses.
Time frame: At 1 year
Distant brain control
Aalen-Johansen estimates will be used for distant brain recurrence. Uni- and multi-variable analysis of time to distant brain recurrence will be done using Fine-Gray proportional hazards regression. Model assumptions will be verified graphically by residual analyses.
Time frame: At 1 year
Overall survival (OS)
Kaplan-Meier estimates will be utilized for survival. Uni- and multi-variable analysis of overall survival will be done with Cox proportional hazards regression.
Time frame: At 1 year
Delta radiomics
Radiomic texture features and changes in features at diagnosis with pathology and over time will be included in various classifiers for modeling including decision trees, discriminate analysis, and nearest neighbor classifiers using classification learner in Matlab.
Time frame: Up to 4 years
Circulating tumor cell analysis
Time frame: Up to 4 years
Cerebral spinal fluid analysis
Time frame: Up to 4 years
Neurocognitive function measured by HVLT-R questionnaire
Measured by neurocognitive decline on Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Up to 1 year from start of treatment
Symptom burden questionnaire
Measured by the MD Anderson Symptom Inventory Brain Tumor (MDASI-BT).
Time frame: Up to 1 year from start of treatment
Health outcomes questionnaire
Measured by the European Quality of Life Five Dimension Five Level Scale questionnaire (EQ-5D-5L).
Time frame: Up to 1 year from start of treatment
Neurocognitive function measured by COWA questionnaire
Measured by neurocognitive decline on Controlled Oral Word Association (COWA)
Time frame: Up to 1 year from start of treatment
Neurocognitive function measured by TMT questionnaire
Measured by neurocognitive decline on and Trail Making Test (TMT) parts A and B
Time frame: Up to 1 year from start of treatment
Neurocognitive function measured by CTB COMP questionnaire
Measured by neurocognitive decline on Clinical Trial Battery Composite (CTB COMP) score.
Time frame: Up to 1 year from start of treatment
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M.D. Anderson Cancer Center