Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Stereotactic Radiosurgery
RadiationUndergo SRS
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Group I (pre-operative SRS)Experimental treatment 3 interventions
Group B: Group II (post-operative SRS)Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
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 year2
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 year3
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 yearOther outcomes
1
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 years2
Circulating tumor cell analysis
Time frame
Up to 4 years3
Cerebral spinal fluid analysis
Time frame
Up to 4 years4
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 treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov