A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS for Brain Metastases
M.D. Anderson Cancer Center
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.
Description
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 feature…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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)…
Interventions
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
- RadiationStereotactic Radiosurgery
Undergo SRS
Location
- M D Anderson Cancer CenterHouston, Texas