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
Qualifiers
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
Treatments tested in this trial
- Quality-of-Life Assessment
- Questionnaire Administration
- Stereotactic Radiosurgery
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov